Lancet-integrated sensor, measurer for lancet-integrated sensor, and catridge

ABSTRACT

A sensor and a lancet are integrated with each other to facilitate replacement and management thereof, and further, portability thereof is improved.  
     That is, a thin strip-shaped sensor ( 1 ) and a lancet ( 2 ) are integrated so that the lancet ( 2 ) moves in parallel, along the longitudinal direction of the sensor ( 1 ).  
     On the other hand, a measuring device to which an integrated lancet and sensor  10  is attached is provided with a function of driving the attached lancet.

TECHNICAL FIELD

[0001] The present invention relates to a lancet-integrated sensor forextracting bodily fluid of a man or an animal, and easily analyzing thecharacteristics of the bodily fluid and, more particularly, to animproved lancet-integrated sensor that is characterized by aconstruction in which a lancet for lancing skin to extract bodily fluidis integrated with a sensor for collecting the bodily fluid extracted atthe surface of the skin to analyze it.

[0002] Further, the present invention relates to a measuring device formeasuring components of bodily fluid such as blood sugar and, moreparticularly, to an improved measuring device for a lancet-integratedsensor.

[0003] Furthermore, the present invention relates to an improvedcartridge for housing biosensors of this type.

BACKGROUND ART

[0004] Conventionally, as a device for easily analyzing thecharacteristics of bodily fluid of a man or an animal, for example, adevice for electrochemically measuring blood sugar has already been putto practical use.

[0005] A biosensor is a device of this type, and hereinafter, abiosensor and a measuring device to be combined with the biosensor willbe described.

[0006]FIG. 21 shows a long and narrow strip-shaped sensor 31 forcollecting blood, which is set in a sensor insertion slot 31 a of ameasuring device 32. The sensor 31 is provided with a cavity (not shown)for collecting blood, in its semi-circular front end that protrudes fromthe measuring device 32 in the state where the sensor 31 is housed inthe measuring device 32. Further, the sensor 31 is provided with, in thecavity, a reagent layer containing an enzyme, an electron carrier, andthe like, and electrodes.

[0007] The measuring device 32 contains an electric circuit formeasuring a current value according to the concentration of glucose inblood, which current is generated by a reaction between the glucose inblood and the reagent layer, by applying a voltage to the electrode, andthe measured blood sugar is displayed on a display 33 which is placed onthe upper surface of the measuring device 32.

[0008] For every measurement, a new sensor 31 is inserted into thesensor insertion slot on the side surface of the measuring device 32,and blood of a patient is applied onto the sensor 31 to performmeasurement. The sensor 31 after measurement is discarded for hygienicreasons.

[0009] Usually, the skin of a body part, such as a fingertip, is lancedwith a lancet device 34 as shown in FIG. 22(a) to extract a very smallquantity of blood, and the blood is collected in the cavity of thesensor 31.

[0010] In the lancet device 34 whose internal structure is shown in FIG.22(b), a force is elastically applied to a lancet 35 by a spring coil36. When an operation button 37 is pushed, an engagement member 37 awhich is united with the operation button 37 is disengaged from aring-shaped groove 35 a of the lancet 35, whereby the force applied tothe lancet 35 by the spring 36 is released, and the tip of a needle 35 bof the lancet 35 forcibly projects from the front end of anapproximately cylindrical-shaped case 38. The lancet 35 comprises theneedle 35 b which is made of metal, and a holder 35 c for holding theneedle 35 b, which is made of plastic. Usually, the lancet 35 isreplaced with a new one at every measurement, for hygienic reasons.

[0011] Further, a biosensor to be used for analyzing bodily fluidextracted from a man or an animal is usually preserved in the statewhere it is wrapped with an aluminum wrapper or the like, or in thestate where it is contained in a plastic case. When the biosensor isused, it is taken out of the aluminum wrapper or the plastic case.

[0012]FIG. 23(a) is a diagram illustrating the state where a biosensor110 having a reagent layer (not shown) for analyzing bodily fluid, andan electrode (not shown) for taking out an electric signal according tothe result of analysis, is hermetically wrapped with an aluminum wrapper120. To be specific, a biosensor 110 which comprises an approximatelyrectangle-shaped plate member having a shorter side of an approximatelysemi-circular shape is wrapped with an aluminum wrapper 120 having arectangle shape that is a little larger than the biosensor 110. FIG.23(b) shows the state where a plurality of biosensors 110, which arearranged with their approximately-semi-circular-shaped ends turningupward and their surfaces being in contact with each other, arehermetically contained in a cylindrical plastic case 130 with a lid.

[0013] When performing measurement, the biosensor 110 which is preservedas shown in FIG. 23(a) or 23(b) is taken out, and the other shorter sideof the biosensor 110, which is not theapproximately-semi-circular-shaped side, is inserted in a biosensorinsertion slot 114 a of a measuring device 114 to prepare formeasurement as shown in FIG. 24.

[0014] Since the conventional biosensor and measuring device thereof areconstructed as described above, when preparing for measurement, apatient sets a new lancet 35 in the lancet device 34 as described above.Then, the patient sets a new sensor 31 in the measuring device 32,whereby preparation for measurement is completed. Thereafter, thepatient operates the lancet device 34 to take blood from his/herfingertip or the like, and applies it onto the front end of the sensor31 that is set in the measuring device 32 to perform measurement. Inthis way, the patient must perform replacement of the lancet andreplacement of the sensor separately for every measurement, resulting incomplicated operation.

[0015] Further, since it is necessary to monitor blood sugar a few timesa day, the sizes of these devices are reduced in consideration ofportability. In the conventional system, however, the patient must carrythe sensor 31, the measuring device 32, the lancet 35, and the lancetdevice 34 together, resulting in a voluminous system as a whole.Further, since the patient must manage the sensor 31 and the lancet 35separately, operation and measurement are troublesome, resulting in poorusability.

[0016] The present invention is made to solve the above-mentionedproblems and has for its object to provide a lancet-integrated sensor inwhich a sensor and a lancet are integrated to facilitate operation andmanagement, and improve portability, as well as a measuring device to becombined with the lancet integrated sensor.

[0017] Further, with respect to the conventional biosensors, asdescribed above, each biosensor is wrapped with an aluminum wrapper, orplural biosensors are stored in a plastic case with a lid, whereby thebiosensors are prevented from contamination due to moisture.

[0018] However, when preparing for measurement, the patient must breakthe aluminum wrapper 120 to take the biosensor 110 or open the lid 130 aof the plastic case 130 to take the biosensors 110 one by one. Further,the patient must insert the taken biosensor 110 toward the sensorinsertion slot 114 a of the measuring device 114. Therefore, preparationfor measurement is troublesome, and the usability is poor.

[0019] The present invention is made to solve the above-mentionedproblems and has for its object to provide a biosensor cartridge bywhich a biosensor stored in a case is easily inserted into a measuringdevice without troublesome operation.

DISCLOSURE OF THE INVENTION

[0020] To be specific, in order to solve the above-mentionedconventional problems, a lancet-integrated sensor-according to claim 1of the present invention is constituted by integrating a lancet forlancing the skin of a subject to extract its bodily fluid, and a sensorbody for analyzing the extracted bodily fluid; the sensor body has ashape of a long and narrow strip; and the lancet is driven along thelongitudinal direction of the sensor body by an external driving means,thereby lancing the skin.

[0021] Accordingly, the sensor and the lancet are integrated with eachother, whereby the sensor and the lancet can be managed not separatelybut together, resulting in easy handling. When measuring the bodilyfluid, since the sensor and the lancet can be set as a single unit on ameasuring device, the operability is improved. Further, thelancet-integrated sensor is convenient to carry about. Furthermore,since the lancet is movable along the longitudinal direction of the longand narrow strip-shaped sensor, the size of the lancet-integrated sensoris reduced, resulting in easy handling.

[0022] Further, according to claim 2 of the present invention, in thelancet-integrated sensor defined in claim 1, the sensor body has aninternal space through which the lancet can pass, and holds the lancetin the space.

[0023] Accordingly, the lancet is held in the sensor, thereby providinga specific construction for further reducing the size of thelancet-integrated sensor.

[0024] Further, according to claim 3 of the present invention, in thelancet-integrated sensor defined in claim 2, a long and narrow space forhousing the lancet is formed in the sensor body.

[0025] Accordingly, the long and narrow space facilitates positioning ofthe lancet and the sensor, whereby a space for attachment of the sensorand the lancet, and a space for moving the lancet can be secured.

[0026] Further, according to claim 4 of the present invention, in thelancet-integrated sensor defined in any of claims 1 to 3, the sensorbody is obtained by bonding two thin plates together, and at least oneof the two plates has a concave portion; and the lancet is stored in aspace which is formed by the concave portion of the two plates bondedtogether.

[0027] Accordingly, a thinner lancet-integrated sensor can be provided.

[0028] Further, according to claim 5 of the present invention, in thelancet-integrated sensor defined in any of claims 1 to 4, when thelancet lances the skin to extract the bodily fluid, the lancet projectsits needle tip from the inside of the sensor body in which the lancet isstored.

[0029] Accordingly, the needle tip of the lancet is housed in thesensor, whereby safely is further improved.

[0030] Further, according to claim 6 of the present invention, in thelancet-integrated sensor defined in any of claims 1 to 5, a cavity forcollecting the bodily fluid is provided separately from the space in thesensor body where the lancet is housed.

[0031] Accordingly, the risk of damaging the inside of the cavity forcollecting the bodily fluid by the lancet is avoided.

[0032] Further, according to claim 7 of the present invention, in thelancet-integrated sensor defined in many of claims 1 to 6, the space inthe sensor body for housing the lancet also serves as a cavity forcollecting the bodily fluid; and the bodily fluid is collected into thespace for housing the lancet.

[0033] Accordingly, the bodily fluid is collected into the space wherethe lancet moves to lance the skin, whereby the size of thelancet-integrated sensor is further reduced.

[0034] Further, according to claim 8 of the present invention, in thelancet-integrated sensor defined in any of claims 1 to 6, an inlet of acavity for collecting the bodily fluid is provided at an end of thesensor from which the needle tip of the lancet is projected.

[0035] Accordingly, the bodily fluid is stored in the cavity at thefront end of the sensor from which the needle tip protrudes, whereby thetime during which the collected bodily fluid is exposed to the air isminimized.

[0036] Further, according to claim 9 of the present invention, in thelancet-integrated sensor defined in any of claims 1 to 8, the sensorbody has, in a cavity, an electrode for outputting the analysis resultof the characteristics of the bodily fluid.

[0037] Accordingly, the characteristics of the bodily fluid can beelectrically measured.

[0038] Further, according to claim 10 of the-present invention, in thelancet-integrated sensor defined in claim 9, a connection terminal to beconnected with an external measuring device to electrically measure thecharacteristics-of the bodily fluid is provided at an end of the sensorbody having the cavity.

[0039] Accordingly, the characteristics of the bodily fluid can beelectrically measured by the external measuring device that is connectedto the sensor.

[0040] Further, according to claim 11 of the present invention, in thelancet-integrated sensor defined in any of claims 1 to 10, a reagentthat reacts with the collected bodily fluid is provided in the cavity.

[0041] Accordingly, the characteristics of the bodily fluid can beoptically or electrochemically measured by a chemical reaction betweenthe reagent and the bodily fluid.

[0042] Further, according to claim 12 of the present invention, in thelancet-integrated sensor defined in any of claims 1 to 10, an end of thelancet on the side opposite to the needle tip projects from the sensorbody; and the projecting end is engaged with a driving means of theexternal measuring device, whereby the lancet is driven to perform theskin lancing operation.

[0043] Accordingly, the external driving means for driving the lancetcan hold the base end of the lancet, and drive the lancet in thelongitudinal direction of the sensor to make the lancet perform thelancing operation.

[0044] Further, according to claim 13 of the present-invention, in thelancet-integrated sensor defined in claim 12, a connector to be engagedwith the driving means of the external measuring device is provided atthe end of the lancet on the opposite side to the needle tip; and theconnector is engaged with the driving means, whereby the lancet performsthe skin lancing operation.

[0045] Accordingly, the external driving means for driving the lancetcan easily hold the base end of the lancet to drive the lancet morereliably.

[0046] Further, according to claim 14 of the present invention, in thelancet-integrated sensor defined in claim 13, the connector is made of aresin, and has a diameter larger than that of the lancet.

[0047] Accordingly, the external driving means for driving the lancetcan easily hold the base end of the lancet to drive the lancet morereliably.

[0048] Further, according to claim 15 of the present invention, in thelancet-integrated sensor defined in any of claims 1 to 14, a detachableprotection cover is fitted to the needle tip of the lancet; and theprotection cover is removed during the skin lancing operation of thelancet.

[0049] Accordingly, injury by the needle tip of the lancet, andcontamination of the needle tip are avoided.

[0050] Further, according to claim 16 of the present invention, in thelancet-integrated sensor defined in claim 15, the protection cover has atube part for housing the needle tip in it, and a wide grip part forfacilitating removal of the protection cover from the lancet, which grippart is provided on the needle tip side of the tube part.

[0051] Accordingly, removal of the protection cover that covers theneedle tip of the lancet is facilitated.

[0052] Further, according to claim 17 of the present invention, in thelancet-integrated sensor defined in claim 15, engagement of the lancetand the driving means, and attachment of the sensor body integrated withthe lancet to the measuring device are performed with holding the grippart of the protection cover.

[0053] Accordingly, the user can attach the sensor and the lancet to themeasuring device by griping the protection cover, without holding thesensor and the lancet.

[0054] Further, according to claim 18 of the present invention, in thelancet-integrated sensor defined in claim 16, a space in which the frontend of the sensor body can be housed is formed in the tube part.

[0055] Accordingly, the sensor, which is fitted to the externalmeasuring device and has finished measurement, can be set so that itsfront end is housed in the protection cover. Then, the used sensor inthis state can be removed from the measuring device to be hygienicallydisposed of.

[0056] Further, according to claim 19 of the present invention, thelancet-integrated sensor defined in any of claims 1 to 18 is providedwith a holder which covers the periphery of the integrated sensor bodyand lancet to hold them.

[0057] Accordingly, the periphery of the integrated sensor and lancet iscovered with the holder, and the user can easily handle thelancet-integrated sensor by griping the holder.

[0058] Further, according to claim 20 of the present invention, in thelancet-integrated sensor defined in claim 19, the holder is made of atransparent material.

[0059] Accordingly, the sensor and the lancet in the holder can beeasily checked, whereby handling is further facilitated.

[0060] Further, according to claim 21 of the present invention, thelancet-integrated sensor defined in any of claims 1 to 20 is of adisposal type, which will be discarded after performing collection andanalysis of the bodily blood one time.

[0061] Accordingly, not only the sensor but also the lancet arenecessarily renewed for every measurement, these devices can behygienically managed.

[0062] Further, according to claim 22 of the present invention, there isprovided a measuring device to which a lancet-integrated sensor that isconstituted by integrating a lancet for lancing the skin of a subject toextract its bodily fluid, and a sensor body for analyzing the extractedbodily fluid, is detachably attached, for measuring the characteristicsof the bodily fluid collected by the lancet-integrated sensor, and themeasuring device includes a lancet driving means for driving, after thelancet-integrated sensor is attached to the measuring device, the lancetso as to lance the skin.

[0063] Accordingly, the conventional lancet device is integrated withthe measuring device, whereby lancing operation and measurement can beperformed by the measuring device alone without requiring a separatelancet device as conventional. Further, since the lancet integrated withthe sensor is attached to the measuring device for every measurement,only the lancet driving means is to be added to the conventionalmeasuring device and, therefore, the measuring device can be realized atlow cost.

[0064] Further, according to claim 23 of the present invention, in themeasuring device defined in claim 22, at least one end of thelancet-integrated sensor is projected from the measuring device whenattachment of the lancet-integrated sensor to the measuring device iscompleted.

[0065] Accordingly, a patient lances his/her fingertip with the lancet,and drops the bodily fluid onto the sensor, with the exposed end of thelancet-integrated sensor as a mark, whereby the operation isfacilitated. Further, since the end of the lancet-integrated sensor isexposed, the measuring device is prevented from being contaminated withthe bodily fluid or the like.

[0066] Further, according to claim 24 of the present invention, in themeasuring device defined in claim 22 or 23, the lancet driving meansdrives the lancet of the lancet-integrated sensor so that the needle tipof the lancet is projected from the sensor only when it lances the skinto collect the bodily fluid and, at all other times, the needle tip ishoused in the sensor.

[0067] Accordingly, the needle tip of the lancet is housed in thesensor, whereby safety is further improved.

[0068] Further, according to claim 25 of the present invention, themeasuring device defined in claim 24 is provided with a connector formaintaining electrical connection with an electrode terminal that isplaced at an end of the sensor body of the lancet-integrated sensor, tomeasure the characteristics of the collected bodily fluid by an internalelectric circuit.

[0069] Accordingly, the characteristics of the bodily fluid can beelectrically measured.

[0070] Further, according to claim 26 of the present invention, in themeasuring device defined in any of claims 22 to 25, the lancet drivingmeans drives the lancet when it is engaged with an end of the lancet onthe opposite side to the needle tip, or when a grip part of a protectioncover is griped.

[0071] Accordingly, the external driving means for driving the lancetholds the end of the lancet, and drives the lancet in the longitudinaldirection of the sensor to make the lancet perform the lancingoperation. Further, when a holding part is provided on the end of thelancet, the driving means can easily hold the lancet.

[0072] Further, according to claim 27 of the-present invention, in themeasuring device defined in claim 26, the lancet driving means has aspring for applying a force to the lancet in the longitudinal directionof the sensor, and the force of the spring is released by a press buttonthat is provided on the measuring device to project the lancet.

[0073] Accordingly, the end of the lancet or the holding part is engagedwith an end of the spring, whereby the elasticity of the coil spring isapplied to the lancet.

[0074] Further, according to claim 28 of the present invention, in themeasuring device defined in any of claims 21 to 27, a lancet-integratedsensor as defined in any of claims 15 to 18 is detachably attached tothe measuring device; and attachment of the lancet-integrated sensor tothe measuring device is carried out with the tip of the lancet beingcovered with a protection cover, the sensor is held by the connector ofthe measuring device, and an end of the lancet on the opposite side tothe needle tip is supported by the lancet driving means.

[0075] Accordingly, injury by the needle tip of the lancet, andcontamination of the needle tip are avoided.

[0076] Further, according to claim 29 of the present invention, in themeasuring device defined in any of claims 22 to 28, a lancet-integratedsensor as defined in any of claims 19 to 20 is detachably attached tothe measuring device; and the sensor is held by the connector, and anend of the lancet on the opposite side to the needle tip or the grippart of the protection cover is held by the driving means, in accordancewith the operation of engaging the holder with the measuring device, sothat the sensor and the lancet are attached to the measuring device inthe state where the sensor and the lancet are being held by the holder.

[0077] Accordingly, the periphery of the integrated sensor and lancet iscovered with the holder, and the user can easily handle thelancet-integrated sensor by griping the holder.

[0078] Further, according to claim 30 of the present invention, in themeasuring device defined in any of claims 22 to 29, a lancet-integratedsensor which has been used is ejected from the measuring device bodywithout being touched with hands, by operating an operation button thatis provided on the measuring device body.

[0079] Accordingly, the user can remove the used lancet-integratedsensor from the measuring device without touching it with hands so thatthe hands are not contaminated, whereby infectious diseases or the likeare avoided.

[0080] Further, according to claim 31 of the present invention, in themeasuring device defined in any of claims 22 to 30, the amount ofprojection of the needle tip of the lancet from the front end of thesensor is displayed on a display means that is provided on the measuringdevice body.

[0081] Accordingly, the user can certainly confirm the amount ofprojection of the needle tip of the lancet with the display means,whereby usability is improved.

[0082] Further, according to claim 32 of the present invention, there isprovided a lancet-integrated sensor which is-constituted by integratinga lancet having a needle for lancing skin to collect bodily fluid, and asensor for analyzing the collected bodily fluid, wherein a cavity forslidably housing a part of the lancet is formed in the sensor, and aforce is applied to the lancet in a direction opposite to the directionalong which the needle lances the skin, to house the needle in thesensor, whereby the lance and the sensor are locked with each other.

[0083] Accordingly, the lancet onto which the bodily fluid sticks islocked in the sensor, whereby the user can safely remove thelancet-integrated sensor from the measuring device without touching theneedle tip with hands by mistake.

[0084] Further, according to claim 33 of the present invention, in thelancet-integrated sensor defined in claim 32, the lancet comprises anapproximately-rectangle-shaped plate member; the needle of the lancet isarranged in the vicinity of the center of one of the shorter sides ofthe plate member so that it projects along the longitudinal direction ofthe plate member; the cavity is formed in a shape approximatelyidentical to an outline shape that is obtained when the lancet is slidby a predetermined amount along the longitudinal direction thereof; andopenings for projecting the needle and the other side of the lancet tothe outside of the sensor are formed at the front end and the rear endof the sensor, respectively.

[0085] Accordingly, the lancet onto which the bodily fluid sticks islocked in the sensor, whereby the user can safely remove thelancet-integrated sensor from the measuring device without touching theneedle tip with hands by mistake.

[0086] Further, according to claim 34 of the present invention, in thelancet-integrated sensor defined in claim 32 or 33, either a convexportion for locking or a concave portion for locking is formed on thelancet, and either a concave portion for locking or a convex portion forlocking which is engaged with the convex portion or the concave portionof the lancet is formed on the sensor; and the lancet and the sensor arelocked with each other when the convex portion for locking and theconcave portion for locking are engaged with each other.

[0087] Accordingly, the lancet onto which the bodily fluid sticks islocked in the sensor, whereby the user can safely remove thelancet-integrated sensor from the measuring device without touching theneedle tip with hands by mistake.

[0088] Further, according to claim 35 of the present invention, in thelancet-integrated sensor defined in claim 34, the lancet has twoplate-shaped projections which project from the two longer sides of thelancet in the width direction; the projections have the concave portionsfor locking on their upper surfaces; a cavity for slidably housing thelancet, which is formed in the sensor, has two depressions for housingthe two projections of the lancet, which depressions project in thewidth direction of the cavity; and the depressions have the concaveportions for locking at their ceilings.

[0089] Accordingly, the lancet onto which the bodily fluid sticks islocked in the sensor, whereby the user can safely remove thelancet-integrated sensor from the measuring device without touching theneedle tip with hands by mistake.

[0090] Further, according to claim 36 of the present invention, themeasuring device for performing measurement using a lancet-integratedsensor, which is defined in claim 33, comprises a guide member forguiding the lancet-integrated sensor that is inserted from an openingprovided on a side surface of the measuring device, thereby restrictingthe direction along which the lancet-integrated sensor travels in themeasuring device; a lancet pressing member which is pushed by a springmember in the measuring device in a direction opposite to the directionalong which the lancet-integrated sensor is inserted, and is engagedwith the other shorter side of the lancet that is guided toward theinside of the measuring device by the guide member, thereby pressing thelancet toward the opening; a locking member for fixing the lancetpressing member at a predetermined position in the measuring device whenthe lancet-integrated sensor is inserted deeper into the measuringdevice; an unlocking member for releasing fixation of the lancetpressing member by the locking member, with manual operation; and anejection member for applying a force-to the sensor of thelancet-integrated sensor to push the sensor toward the opening side,with manual operation, which ejection member is provided between thelancet pressing member and the guide member.

[0091] Accordingly, it is possible to realize a measuring device whichcan perform measurement using a lancet-integrated sensor that can besafely removed from the measuring device because the lancet to which thebodily fluid sticks is locked in the sensor to prevent the hands of theuser from touching the needle tip by mistake and, after the measurement,the lancet-integrated sensor can be safely removed from the measuringdevice with the needle tip being housed in the sensor.

[0092] Further, according to claim 37 of the present invention, in themeasuring device for a lancet-integrated sensor which is defined inclaim 36, the ejection member slides an operation lever that is exposedat the main surface of the measuring device, toward the opening side,whereby a pressing member that is united with the operation leverpresses the vicinity of both sides of an end of the lancet-integratedsensor, which end is opposite to the side where the lancet lances theskin, thereby ejecting the lancet-integrated sensor.

[0093] Accordingly, it is possible to realize a measuring device whichcan perform measurement using a lancet-integrated sensor that can besafely removed from the measuring device because the lancet to which thebodily fluid sticks is locked in the sensor to prevent the hands of theuser from touching the needle tip by mistake and, after the measurement,the lancet-integrated sensor can be safely removed from the measuringdevice with the needle tip being housed in the sensor.

[0094] Further, according to claim 38 of the present invention, there isprovided a measuring device for performing measurement using alancet-integrated sensor which is constituted by integrating a lancetfor lancing skin to collect bodily fluid, and a sensor for analyzing thecollected bodily fluid, wherein the measuring device for thelancet-integrated sensor has an opening on a side surface; the measuringdevice has a cavity in which the lancet-integrated sensor can be housed,which cavity is formed corresponding to the opening; a holder attachmentpart is formed on the side of the measuring device having the opening,which holder attachment part detachably attaches a holder body in whichthe lancet-integrated sensor can path through, to the measuring device;and the holder body guides the lancet-integrated sensor when thelancet-integrated sensor is housed in the cavity and, after it is housedin the cavity, the holder body holds a portion of the lancet-integratedsensor in the vicinity of the end where the lancet lances the skin.

[0095] Accordingly, the holder body is constituted to be detachable fromthe measuring device so that replacement or washing of the holder bodyis easily carried out, and the measuring device can be used not only bya specific user but also by other persons, whereby the measuring devicefor the lancet-integrated sensor-can be safely and hygienically used.

[0096] Further, according to claim 39 of the present invention, in themeasuring device for a lancet-integrated sensor which is defined inclaim 38, engagement portions of the holder and the holder attachmentpart have asymmetrical shapes in the vertical direction or in thehorizontal direction; and attachment of the holder to the holderattachment part is possible only when the vertical direction of theholder with respective to the holder attachment part is a predetermineddirection.

[0097] Accordingly, the holder body can always be inserted into themeasuring device in the normal direction, and the lancet-integratedsensor is prevented from being inserted upside down into the measuringdevice.

[0098] Further, according to claim 40 of the present invention, in themeasuring device for a lancet-integrated sensor which is defined inclaim 38, the opening of the holder attachment part into which theholder body is inserted has a shape of an approximately rectangle thatis side-to-side long, with portions corresponding to the corners of therectangle being rounded, and the opening has smaller openingsoverhanging in the width direction in the vicinities of the centers oftwo sides in the longitudinal direction.

[0099] Accordingly, the opening of the holder attachment part becomesasymmetrical in the longitudinal direction and in the width direction,whereby the holder is prevented from being inserted in a wrongdirection.

[0100] Further, according to claim 41 of the present invention, in themeasuring device for a lancet-integrated sensor which is defined inclaim 40, the holder body has hinge-shaped stoppers; inner sides of thehinge-shaped stoppers are fixed to the holder body; and outer sides ofthe hinge-shaped stoppers are engaged with the engagement portions ofthe holder attachment part.

[0101] Accordingly, the holder body can always be inserted into themeasuring device in the normal direction, and the lancet-integratedsensor is prevented from being inserted upside down into the measuringdevice.

[0102] Further, according to claim 42 of the present invention, in themeasuring device for a lancet-integrated sensor which is defined inclaim 40, the holder body has a peripheral edge part that extends alongthe surface of the opening at the periphery of the opening excluding thesmaller openings, on the side where the holder body is attached to themeasuring device; the hinge-shaped stoppers are provided in portions ofthe peripheral edge part corresponding to the smaller openings; and thehinge-shaped stoppers are obtained by extending band-shaped elasticmembers in the direction along which the lancet-integrated sensor isimpacted into the holder body, and bending the elastic members outwardat 180°.

[0103] Accordingly, the holder body is attached to the measuring devicewith stability, by the extending force due to the elasticity of thestopper.

[0104] Further, according to claim 43 of the present invention, in themeasuring device for a lancet-integrated sensor which is defined inclaim 42, each of the hinge-shaped stoppers has a clip member at thefront end of the band-shaped elastic member, which clip member isthicker than the elastic member, and performs positioning when theholder body is latched in the opening.

[0105] Accordingly, the front end of each stopper is engaged with theinside of the smaller opening of the measuring device so as to preventdisconnection of the stopper from the smaller opening, whereby theholder body is attached to the measuring device with stability.

[0106] Further, according to claim 44 of the present invention, there isprovided a biosensor cartridge for housing plural biosensors, eachhaving a reagent layer for detecting a specific component in bodilyfluid of a subject, and an electrode for taking out an electric signalindicating that the reagent layer detects the specific component,wherein a cartridge body has, at an end of its upper surface, a hingefor rotatably fixing a lid that covers the cartridge; the cartridge bodyhas plural slits for perpendicularly supporting the respectivebiosensors; and the plural slits are formed in parallel with each other,from the upper surface toward the lower surface of the cartridge body,at regular intervals which allow an insertion slot of a measuring devicefor performing measurement using a target biosensor to be insertedwithout touching biosensors adjacent to the target biosensor.

[0107] Accordingly, the user can attach the sensor to the measuringdevice by only opening the lid and pressing the sensor-insertion slot ofthe measuring device onto the sensor. Therefore, troublesome preparationfor measurement, i.e., holding the sensor with hands to insert it intothe measuring device at every measurement, is saved, resulting inimproved usability.

[0108] Further, according to claim 45 of the present invention, in thebiosensor cartridge defined in claim 44, the cartridge body to which thelid is attached is a rectangular parallelepiped in shape.

[0109] Accordingly, the user can attach the sensor to the measuringdevice by only opening the lid and pressing the sensor insertion slot ofthe measuring device onto any of the sensors which are supported atregular intervals by the rectangular parallelepiped cartridge body.Therefore, troublesome preparation for measurement, i.e., holding thesensor with hands to insert it into the measuring device at everymeasurement, is saved, resulting in improved usability.

[0110] Further, according to claim 46 of the present invention, in thebiosensor cartridge defined in claim 45, the lid is a hollow rectangularparallelepiped in shape, and has an opening at a portion opposed to theupper surface of the cartridge body.

[0111] Accordingly, the user can attach the sensor to the measuringdevice by only opening the hollow and rectangular parallelepiped lid,and pressing the sensor insertion slot of the measuring device onto anyof the sensors which are supported at regular intervals by therectangular parallelepiped cartridge body. Therefore, troublesomepreparation for measurement, i.e., holding the sensor with hands toinsert it into the measuring device at every measurement, is saved,resulting in improved usability.

[0112] Further, according to claim 47 of the present invention, in thebiosensor cartridge defined in claim 44, the bottom of each slit has ashape that conforms to the shape of the front end of the biosensor.

[0113] Accordingly, the bottom of each slit of the cartridge bodyconforms to the shape of the front end of the biosensor so that nostress is applied to a specific portion of the front end of thebiosensor, whereby the biosensor can be supported with reliability.

[0114] Further, according to claim 48 of the present invention, in thebiosensor cartridge defined in claim 47, the front end of the biosensoris semi-circular in shape.

[0115] Accordingly, the bottom of each slit of the cartridge bodyconforms to the semi-circular shape of the front end of the biosensor sothat no stress is applied to a specific portion of the front end of thebiosensor, whereby the biosensor can be supported with reliability.

[0116] Further, according to claim 49 of the present invention, in thebiosensor cartridge defined in claim 44, the hinge is constituted by apair of bearings each having a side-to-side long bearing hole thatprojects outward along the longitudinal direction of the cartridge bodyfrom an end of the upper surface of the cartridge body, and a pair ofaxial projections which are provided at an end of the lid, and serve asfulcra when being smooth-movably engaged with the bearings to rotate thelid; a peripheral edge part is formed at the periphery of the uppersurface of the cartridge body, which part extends in a directionperpendicular to the side walls of the cartridge body, and has pluralnotches; reverse-L-shaped projections are formed on the same plane asthe side walls of the lid, in positions corresponding to the notches ofthe peripheral edge part, at the periphery of the opening of the lid;and a sealing member having elasticity is formed on the upper surface ofthe peripheral edge part.

[0117] Accordingly, after the lid is closed, the lid is slid in thehorizontal direction so that the reverse-L-shaped projections on the lidare engaged with the notches of the peripheral edge part of thecartridge body, whereby the sealing member having elasticity adheresclosely to the edge of the opening of the lid and to the peripheral edgepart of the cartridge body, and the hermeticity in the cartridge isincreased, thereby preventing the sensor from being contaminated withthe moisture.

[0118] Further, according to claim 50 of the present invention, there isprovided a biosensor cartridge for housing plural lancet-integratedbiosensors, each being constituted by integrating a biosensor having areagent layer for detecting a specific component in bodily fluid of asubject, and an electrode for taking out an electric signal indicatingthat the reagent layer detects the specific component, with a lancet forcollecting the bodily fluid of the subject, wherein the cartridge bodyhas, at an end of its upper surface, a hinge for rotatably fixing a lidthat covers the cartridge body; the cartridge body has plural groovesfor perpendicularly supporting the lancet-integrated biosensors; and theplural grooves are formed in parallel with each other, from the uppersurface toward the lower surface of the cartridge body, at regularintervals which allow an insertion slot of a measuring device forperforming measurement using a target biosensor to be inserted withouttouching biosensors adjacent to the target biosensor.

[0119] Accordingly, the user can attach the lancet-integrated sensor tothe measuring device by only opening the lid and pressing the sensorinsertion slot of the measuring device onto the sensor. Therefore,troublesome preparation for measurement, i.e., holding thelancet-integrated sensor with hands to insert it into the measuringdevice at every measurement, is saved, resulting in improved usability.

[0120] Further, according to claim 51 of the present invention, in thebiosensor cartridge defined in claim 50, the lancet-integrated biosensorincludes an approximately-square-shaped and narrow protector forprotecting the lancet that projects from the lancet-integrated biosensorin its unused state; a sensor body in which the lancet is smooth-movablyhoused, the sensor body being approximately rectangle in shape, has afront end being semi-circular in shape, and is a little wider than theprotector; and a connector which is provided on the lancet, protrudesbackward from the sensor body, and has a width approximately equal tothe width of the sensor body; wherein each of the plural groovescomprises a narrow first groove which is provided at the lowest surfaceside of the cartridge body, and conforms to the shape of the protector;a second groove which is wider than the first groove, is provided abovethe first groove, and conforms to the shape of a portion of the sensorbody; and a third groove which is wider than the second groove, isprovided above the second groove, and conforms to the shape of theinsertion slot part of the measuring device into which the sensor bodyis inserted.

[0121] Accordingly, the lancet-integrated sensors each having acomplicated shape can be supported at regular intervals, and the usercan attach the lancet-integrated sensor to the measuring device by onlypressing the sensor insertion slot of the measuring device onto thesensor. Therefore, troublesome preparation for measurement, i.e.,holding the sensor with hands to insert it into the measuring device atevery measurement, is saved, resulting in improved usability.

[0122] Further, according to claim 52 of the present invention, in thebiosensor cartridge defined in claim 51, the insertion slot stores thesensor body into a cavity which penetrates a pillar-shaped projectionthat projects from a side surface of the measuring device; and theconnector is stored in the cavity that extends into the measuringdevice.

[0123] Accordingly, the user can attach the lancet-integrated sensorhaving a complicated rear-end shape to the measuring device by onlypressing the sensor insertion slot of the measuring device onto thesensor. Therefore, troublesome preparation for measurement, i.e.,holding the sensor with hands to insert it into the measuring device atevery measurement, is saved, resulting in improved usability.

[0124] Further, according to claim 53 of the present invention, there isprovided a measuring device for performing measurement using alancet-integrated sensor that is attached thereto, the lancet-integratedsensor being constituted by integrating a lancet for lancing skin tocollect bodily fluid, and a sensor for analyzing the extracted bodilyfluid, and the measuring device includes a drive means for driving thelancet in a direction in which the lancet lances the skin, along thelongitudinal direction of the sensor, from the standby position of thelancet; wherein, after the drive means has driven the lancet in thedirection in which the lancet lances the skin, the drive means can drivethe lancet back to the standby position while maintaining the statewhere the lancet-integrated sensor is attached to the measuring device.

[0125] Accordingly, even when the lancet fails to lance the skin in theprocess of collecting the bodily fluid,: or measurement cannot becarried out due to some problem, re-preparation for measurement can beeasily carried out, whereby usability of the measuring device for thelancet-integrated sensor is further improved.

[0126] Further, according to claim 54 of the present invention, in themeasuring device for a lancet-integrated sensor which is defined inclaim 53, the drive means has a shaft to which a connector receiver isfixed at an end on the side where the lancet lances the skin, whichconnector receiver receives an end of the lancet on the side opposite tothe side where the lancet lances the skin; a pull stick for driving thelancet back in a direction opposite to the direction in which the lancetlances the skin is disposed on an end of the shaft on the side oppositeto the side where the lancet lances the skin; and the connector receiveris provided with a claw portion which is unlocked by pressing anoperation button to start the operation of the drive means, and stopsthe motion of the connector receiver against a force applied by a springthat is provided on the shaft to move the connector receiver in thedirection in which the lancet lances the skin.

[0127] Accordingly, even when the lancet fails to lance the skin in theprocess of collecting the bodily fluid, or measurement cannot be carriedout due to some problem, re-preparation for measurement can be easilycarried out by operating the pull stick, whereby usability of themeasuring device for the lancet-integrated sensor is further improved.

[0128] Further, according to claim 55 of the present invention, in themeasuring device for a lancet-integrated sensor which is defined inclaim 54, the measuring device has, in its internal cavity, a supportmember for slidably supporting the shaft in the vicinity of its center;and the spring is a coil spring which is placed between the supportmember of the shaft and the connector receiver.

[0129] Accordingly, the shaft is supported in the measuring device, andthe coil spring which is placed between the support member and theconnector receiver supplies a force for driving the lancet.

[0130] Further, according to claim 56 of the present invention, in themeasuring device for a lancet-integrated sensor which is defined inclaim 54, the pull stick has an opening which is formed at an end of theside where the lancet lances the skin; an end of the shaft on the sideopposite to the side where the lancet lances the skin is slidably housedin the pull stick through the opening; the end of the shaft on the sideopposite to the side where the lancet lances the skin has a slip-outprevention member for preventing the end of the shaft to slipping out ofthe pull stick toward the side where the lancet lances the skin.

[0131] Accordingly, the shaft can be drawn out in the-lancet projectingdirection and in the opposite direction by pulling the pull stick.

[0132] Further, according to claim 57 of the present invention, in themeasuring device for a lancet-integrated sensor which is defined inclaim 54, the driving means is provided with a lancet projection amountadjuster for adjusting the amount of projection of the needle of thelancet that lances the skin, which driving means is placed between themeasuring device and the pull stick.

[0133] Accordingly, the amount of projection of the needle tip of thelancet is adjustable, whereby the amount of the bodily fluid oozing outof the skin of the subject can be adjusted, or the pain by being lancedwith the lancet can be reduced.

[0134] Further, according to claim 58 of the present invention, in themeasuring device for a lancet-integrated sensor which is defined inclaim 57, the pull stick is approximately cylindrical in shape, and anend of the pull stick on the side opposite to the side where the lancetlances the skin has a handle part having a portion of a diameter largerthan the diameter of the cylindrical part; the lancet projection amountadjuster is approximately cylindrical in shape, and an end of theadjuster on the side opposite to the side where the lancet lances theskin has an opening having a diameter equal to the diameter of thecylindrical part of the pull stick; and the cylindrical part is slidablyhoused through the opening, and the cylindrical part is screwed into ascrew hole that is formed on a-side surface of the measuring device onthe side opposite to the side where the lancet lances the skin, towardthe inside of the measuring device, whereby the cylindrical part rotatesin the screw direction or in the opposite direction to adjust the amountof projection of the lancet.

[0135] Accordingly, the amount of projection of the needle tip of thelancet is adjustable, whereby the amount of the bodily fluid oozing outof the skin of the subject can be adjusted, or the pain by being lancedwith the lancet can be reduced.

BRIEF DESCRIPTION OF THE DRAWINGS

[0136] FIGS. 1(a) and 1(b) are diagrams illustrating a lancet-integratedsensor according to a first embodiment of the present invention, whereinFIG. 1(a) is a perspective view of the whole, and FIG. 1(b) is anexploded perspective view thereof.

[0137] FIGS. 2(a)-2(d) are plan views for explaining the operation ofthe lancet-integrated sensor, wherein FIG. 2(a) shows the state where aneedle tip, which is covered with a protection cover, protrudes from thesensor, FIG. 2(b) shows the state where the needle tip, which is coveredwith the protection cover, is housed in the sensor, FIG. 2(c) shows thestate where the needle tip, from which the protection cover is removed,protrudes from the sensor, and FIG. 2(d) shows the state where theneedle tip, from which the protection cover is removed, is housed in thesensor.

[0138] FIGS. 3(a) and 3(b) are perspective views of a measuring deviceto be combined with the lancet-integrated sensor according to the firstembodiment of the invention, wherein FIG. 3(a) shows its upper surface,and FIG. 3(b) shows its lower surface.

[0139] FIGS. 4(a) and 4(b) are diagrams for explaining the internalstructure of the measuring device, wherein FIG. 4(a) is an explodedperspective view of its lower half side, and FIG. 4(b) is across-sectional view of its side surface.

[0140] FIGS. 5(a)-5(c) are diagrams for explaining the operation forattaching the lancet-integrated sensor to the measuring device, whereinFIG. 5(a) is a sectional side elevation view at starting of theattachment, FIG. 5(b) is a sectional side elevation view at completionof the attachment, and FIG. 5(c) is a sectional view in the vicinity anoperation button.

[0141] FIGS. 6(a) and 6(b) are diagrams illustrating a protection coverof the lancet-integrated sensor according to the first embodiment of theinvention, wherein FIG. 6(a) shows the state where the protection coveris fitted when the needle tip protrudes, and FIG. 6(b) shows the statewhere the protection cover is fitted to a front end of the sensor whenthe needle tip is housed.

[0142]FIG. 7 is a perspective view of a measuring device to be combinedwith the lancet-integrated sensor according to the first embodiment ofthe invention.

[0143] FIGS. 8(a) and 8(b) are diagrams illustrating a lancet-integratedsensor according to a second embodiment of the invention, wherein FIG.8(a) shows a perspective view of the whole, and FIG. 8(b) is an explodedperspective view thereof.

[0144] FIGS. 9(a) and 9(b) are diagrams illustrating thelancet-integrated sensor according to the second embodiment of theinvention and a measuring device for the lancet-integrated sensor,wherein FIG. 9(a) is a perspective view of the measuring device in thestate where the sensor is attached thereto, and FIG. 9(b) is across-sectional view of the measuring device in the state where thesensor is attached thereto.

[0145]FIG. 10 is a diagram for explaining engagement of a fine concaveportion provided in the lancet with a fine convex portion provided inthe sensor.

[0146] FIGS. 11(a) and 11(b) are diagrams illustrating the appearance ofa measuring device for a lancet-integrated sensor according to a thirdembodiment of the invention, wherein FIG. 11(a) shows the state where aholder is attached, and FIG. 11(b) shows the state where the holder bodyis removed.

[0147] FIGS. 12(a)-12(c) are diagrams illustrating the appearance of theholder of the measuring device for a lancet-integrated sensor accordingto the third embodiment of the invention, wherein FIG. 12(a) is anelevational view in the state where the holder is attached to themeasuring device, FIG. 12(b) is a cross-sectional view when the holderattached to the measuring device is viewed from above, and FIG. 12(c) isa cross-sectional view when the holder to be removed from the measuringdevice is viewed from above.

[0148] FIGS. 13(a) and 13(b) are diagrams illustrating the internalstructure of the measuring device which uses a lancet-integrated sensoraccording to the third embodiment of the invention, and anotherconstruction of a lancet-integrated sensor, wherein FIG. 13(a) is across-sectional view of the measuring device in the state where theholder is attached, and FIG. 13(b) is a partially cutawaycross-sectional view of the measuring device in the state where theholder is attached.

[0149]FIG. 14 is a diagram illustrating the appearance of a measuringdevice which uses a lancet-integrated sensor according to a fourthembodiment of the invention.

[0150]FIG. 15 is a cross-sectional view illustrating the internalstructure of the measuring device according to the fourth embodiment ofthe invention.

[0151]FIG. 16 is a cross-sectional view illustrating a biosensorcartridge according to a fifth embodiment of the invention.

[0152] FIGS. 17(a) and 17(b) are diagrams illustrating the state where asensor stored in the biosensor cartridge according to the fifthembodiment of the invention is inserted into a measuring device, whereinFIG. 17(a) shows the state where the sensor is inserted, and FIG. 17(b)shows the state before the sensor is inserted.

[0153] FIGS. 18(a)-18(c) are diagrams illustrating a biosensor cartridgeaccording to a first modification of the fifth embodiment of theinvention, wherein FIG. 18(a) is a perspective view illustrating thestate where a lid is opened, FIG. 18(b) is a side view illustrating thestate wherein the lid is closed, and FIG. 18(c) is a cross-sectionalview illustrating the state where the lid is closed.

[0154]FIG. 19 is a diagram illustrating a biosensor cartridge accordingto a second modification of the fifth embodiment of the invention.

[0155] FIGS. 20(a) and 20(b) are diagrams for explaining attachment of alancet-integrated sensor to a measuring device in the biosensorcartridge according to the second modification of the fifth embodimentof the invention, wherein FIG. 20(a) is a diagram illustrating the statewhere the sensor is attached, and FIG. 20(b) is a diagram illustratingthe state before the sensor is attached.

[0156]FIG. 21 is a perspective view illustrating an example of aconventional measuring device for a biosensor.

[0157] FIGS. 22(a) and 22(b) are diagrams illustrating a conventionallancet device, wherein FIG. 22(a) is a perspective view thereof, andFIG. 22(b) is a perspective view thereof in the state where a part ofthe lancet device is seen through.

[0158] FIGS. 23(a) and 23(b) are diagrams illustrating a conventionalmanner of housing biosensors, wherein FIG. 23(a) shows the state where abiosensor is wrapped with a wrapper, and FIG. 23(b) shows the statewhere plural biosensors are stored in a plastic container.

[0159]FIG. 24 is a diagram illustrating the state where a biosensor isinserted into a measuring device.

BEST MODE TO EXECUTE THE INVENTION

[0160] (Embodiment 1)

[0161] Hereinafter, a first embodiment of the present invention will bespecifically described taking, as an example, a blood sugar sensor forelectrochemically measuring blood sugar, with reference to the drawings.

[0162] The first embodiment relates to a lancet-integrated sensor inwhich a lancet and a sensor are integrated to facilitate management andcarrying, and a measuring device for driving the lancet-integratedsensor, and performing measurement using the sensor. This firstembodiment corresponds to claims 1 to 31 of the present invention.

[0163] That is, in the lancet-integrated sensor according to the firstembodiment, a long and narrow strip-shaped sensor and a lancet areintegrated with each other and, more specifically, the lancet ishorizontally movable along the longitudinal direction of the sensor.

[0164] The measuring device, to which the lancet-integrated sensor isfitted, is provided with a lancet driving function of the conventionallancet device. That is, the measuring device is provided with a drivingmeans for driving the lancet of the lancet-integrated sensor that isfitted thereto.

[0165] In this construction, a patient sets a new lancet-integratedsensor onto the measuring device every time he/she performs measurement.Then, the patient grips the measuring device, and turns on the lancetdriving means to lance his/her fingertip with the lancet. Subsequently,the patient drops blood onto the sensor to measure blood sugar or thelike.

[0166] Hereinafter, the lancet-integrated sensor and the measuringdevice will be described more specifically.

[0167] FIGS. 1(a) and 1(b) are a perspective view and an explodedperspective view of a lancet-integrated sensor according to the firstembodiment of the invention, respectively. With reference to FIG. 1(a),numeral 10 denotes a lancet-integrated sensor, wherein numeral 1 denotesa long and narrow strip-shaped sensor, and numeral 2 denotes a lancet, agreater part of which is housed in a hollow (space) 1 a in the sensor 1,and the lancet 2 is supported by the sensor (sensor body) 1 so as to beslidable in the longitudinal direction of the sensor 1.

[0168] Reference numeral 3 denotes a protection cover into which theneedle tip of the lancet 2 is pressed, thereby protecting the needletip. This cover 3 is removed during measurement. Reference numeral 4denotes electrode terminals for making electrical connection to ameasuring device which is later described. Reference numeral 5 denotes acavity provided at the semi-circular front end of the sensor 1.

[0169] As shown in FIG. 1(b), the construction of the sensor 1 isobtained by bonding a cover (plate) 6 to a substrate (plate) 7 together,which are made of a resin such as polyethylene terephthalate. Further,the lancet 2 comprises a metal needle 2 a, and a connector (end portion)2 b which has the needle 2 a at its front end, and holds the needle 2 a.A rear end portion of the approximately strip-shaped connector 2 bprojects from the rear end of the sensor 1 to be engaged with thedriving means of the measuring device which is described later.

[0170] At the lower surface of the cover 6, concave portions whichconform to the shape of the lancet 2 are provided. More specifically,there are provided a groove (concave portion) 6 a which conforms to theoutline of the connector 2 b so that the connector 2 b is slidablyhoused in it along its longitudinal direction, and a long and narrowgroove (concave portion) 6 b in which the needle 2 a is housed. Thegroove 6 b in which the needle 2 a is housed is extended to the frontend of the sensor 1. Further, a pair of electrodes 8 leading to theelectrode terminals 4 are formed on the surface of the substrate 7, anda reagent layer (not shown) is formed on the surface of the electrodes8.

[0171] In this way, the lancet-integrated sensor is obtained by bondingthe cover 6 and the substrate 7 together, with the lancet 2 being placedbetween them. Accordingly, the cavity 5 also serves as the long andnarrow groove 6 b in which the needle 2 a is housed. Further, portionsof the electrodes 8 and the reagent layer are exposed in the cavity 5.

[0172] As described above, the lancet 2 is movable along thelongitudinal direction of the sensor 1, and its motion will be describedhereinafter with reference to a plan view shown in FIG. 2.

[0173]FIG. 2(a) shows a state where the position of the lancet 2 isclosest to the front end of the sensor 1. That is, each of fineprojections 2 c, which are formed so as to project from the connector 2b in the direction perpendicular to the longer side of the connector 2 bwithin the same plane as the main surface of the connector 2 b, abuts ona side wall 60 b at an end of a wide concave groove (concave portion) 60a on the topmost side of the sensor 1, which groove 60 a is formed inthe cover 6. In this state, a longest portion of the needle 2 a of thelancet 2 projects from the front end of the sensor 1. FIG. 2(b) shows astate where each of the fine projections 2 c of the connector 2 b abutson a side wall 60 c at an end of the concave groove 60 a on the rearmostside of the sensor 1. In this state, the needle of the lancet 2 iscompletely housed in the sensor 1.

[0174] As shown in FIGS. 2(a) and 2(b), the shape of the groove 60 a iscurved such that, at the end where the fine projection 2 c ispositioned, the width of the groove 60 a is a-little narrower than thewidth of the connector 2 b including the fine projection 2 c.Accordingly, at the end of the concave groove 60 a, the connector 2 b islatched by the sensor 1 due to the mutual pressing or friction.

[0175] The construction of the lancet-integrated sensor is as describedabove, and the protection cover 3 is removed for measurement, and afingertip or the like is lanced with the tip of the needle 2 a of thelancet 2 which projects from the opening of the cavity 5, as shown inFIG. 2(c). When blood is dropped onto the sensor 1 and sucked into thecavity 5 to measure blood sugar as shown in FIG. 2(d), the needle tip ofthe lancet 2 is positioned in the groove 6 a which is apart from thecavity 5 so that the needle does not contact the blood sucked into thecavity 5.

[0176] Measuring Device

[0177] Next, an example of a measuring device to be connected with theabove-described lancet-integrated sensor will be described withreference to the drawings.

[0178] FIGS. 3(a) and 3(b) are perspective views of a measuring device11 to which a lancet-integrated sensor is fitted, and FIG. 3(a) mainlyshows its upper surface while FIG. 3(b) mainly shows its lower surface.Reference numeral 12 denotes a display (display means) for displayingthe result of measurement and the like, and numeral 13 denotes a slotinto which the lancet-integrated sensor is inserted. Reference numeral14 denotes a push button (unlocking member) for driving the lancet thatis fitted to the measuring device 11 such that the lancet forciblyprojects to lance a fingertip or the like. Further, reference numeral 15denotes a slide button (ejection member, operation button) for ejectingthe used lancet-integrated sensor from the measuring device 11. Further,reference numeral 16 denotes an adjustment button (lancet projectionamount adjuster) for adjusting the amount of projection of the needletip of the lancet.

[0179]FIG. 4(a) is a perspective view of the measuring device 11 in thestate where an upper portion of a package case is removed to show theinternal structure of the measuring device 11, and FIG. 4(a)specifically shows the connection terminal to be electrically connectedwith the sensor, and the driving means to be engaged with the connectorof the lancet. Further, FIG. 4(b) is a side view of the measuringdevice.

[0180] Reference numeral 17 denotes a pair of guides having connectionterminals to be electrically connected with the electrode terminals ofthe sensor. The guides 17 are planted on the substrate 11 a at thebottom of the package case by resin molding so as to haveapproximately-L-shaped cross sections, and connection terminals areformed on the ceilings of the guides 17. Further, at an end of eachguide 17, which is opposite to a connector receiver 19 b, a terminationmember 17 a is planted to make a dead-end, excluding a space between theguides 17. When fitting the lancet-integrated sensor to the measuringdevice, the sensor 10 is guided by the guides 17 to be set.

[0181] Reference numeral 18 denotes a coil spring (lancet pushingmember) for driving the lancet 2, and numeral 19 denotes a connectreceiver (lancet pushing member) which is engaged with the connector 2 bof the lancet 2. The connector receiver 19 is slidably supported by apair of approximately-inverse-L-shaped supporting members 24 which areplanted on the substrate 11 a, and an end of the coil spring 18 is fixedonto a side of the connector receiver 19, which is opposite to the sidethat is engaged with the sensor 10. The other end of the coil spring 18is supported by a spring stopper (lancet pushing member) 23. When thelancet 2 is engaged with the connector receiver 19 and the lancet 2 ispushed into the measuring device 11, the coil spring 18 is compressed,whereby a force for driving the lancet 2 is applied to the coil spring18.

[0182] Reference numeral 20 denotes a driving lever having a taperedprojection 20 a which is engaged with a tapered projection lic that ispositioned in front of the push button 14. When the lancet 2 is set upto a predetermined position, the driving lever 20 latches the connectorreceiver 19 to hold the driving force. This latching is canceled bypushing the push button 14, and the lancet 2 is driven by the pressingforce-from the spring 18.

[0183] Reference numeral 21 denotes a torsion spring for restricting theposition of the connector receiver 19, and the torsion spring 21 isfixed by a shaft member 25 that is planted in the vicinity of a sidesurface parallel with the insertion path of the sensor 10. The torsionspring 21 pushes the connector receiver 19 that is not latched by thedriving lever 20, in the direction against the elasticity of the coilspring 18. The torsion spring 21 restricts the position of the connectorreceiver 19, in balance with the elasticity of the coil spring 18, sothat the needle tip of the lancet 2 is positioned apart from the cavity5 to prevent the needle chip from contacting the blood drawn into thecavity 5.

[0184] Reference numeral 22 denotes an ejection lever which is unitedwith the slide button 15, and the ejection lever 22 pushes the rear endof the sensor 1 to eject the sensor 1 from the measuring device when theslide button 15 is operated in the direction indicated by an arrow a.

[0185] Measuring Operation

[0186] Hereinafter, a description will be given of a series of measuringoperations, with respect to the lancet-integrated sensor and themeasuring device, which are constructed as described above.

[0187] Initially, an operation for fitting the lancet-integrated sensorto the measuring device will be described. The lancet-integrated sensoris in the state shown in FIG. 2(a) when it is not used. That is, theneedle tip of the lancet 2 projects from the sensor 1, and is coveredwith the protection cover 3. A patient grips a wide grip part 3 a of theprotection cover 3, and inserts the lancet 2, from the connector 2 bside, into the insertion slot 13 of the measuring device 11.

[0188] The patient further pushes the grip part 3 a of the protectioncover 3 to insert the sensor 1 and the lancet 2 deeper into themeasuring device 11. Thereby, as shown in FIG. 5(a), the sensor 1 isguided by the guide 17 to advance into a case 11 b. As the sensor 1continues to advance into the case, the shorter side of the sensor 1,which is opposite to the semi-circular side thereof, touches thetermination member 17 a of the guide 17 to be set at a fixed positionwhere the advance of the sensor 1 into the case 11 b is restricted,whereby the electrode terminals 4 of the sensor 1 are connected to theconnection terminals (not shown) of the measuring device 11. In order tomake FIG. 5(a) easy to see, only the sensor 1 of the lancet-integratedsensor is shown, and a part corresponding to the lancet 2 is omitted.

[0189] Although the advance of the sensor 1 is stopped at this point oftime, since the motion of the lancet 2 is not restricted by thetermination member 17 a of the guide 17 as shown in FIG. 5(c), thelancet 2 can be inserted deeper into the case 11 b. That is, by thepressing force of the protection cover 3, the engagement of the fineprojection 2 c with the concave groove 60 a is released at the positionshown in FIG. 2(a). Then, as shown in FIG. 2(b), the tube 3 b of theprotection cover 3, which protects the needle 2 a, is pushed into thesensor 1, and a side of the grip part 3 a of the protection cover 3touches the front end of the sensor 1.

[0190] When the patient pushes the protection cover 3 deeper than thestate shown in FIG. 5(a), the connector 2 b of the lancet 2 is engagedwith the concave portion 19 a of the connector receiver 19 and, as shownin FIG. 5(b), the coil spring 18 is compressed, whereby the taperedprojection 20 a of the driving lever 20 of the connector receiver 19 islatched by the tapered projection lic in front of the push button 14 tocomplete fitting of the sensor 10.

[0191] Next, a blood collecting operation and a blood dropping operationwill be described. FIG. 3(a) shows the state where fitting of thelancet-integrated sensor to the measuring device is completed. Thepatient holds the measuring device 11, and lightly pushes the front endof the sensor 10 against a portion of his/her body from which blood isto be extracted, such as a fingertip.

[0192] When the patient pushes the push button 14, the lancet 2 isdriven, and the needle tip forcibly projects from the front end of thesensor 10 to lance the skin of the patient. At this time, the amount ofprojection of the needle tip from the sensor is variable by sliding theadjustment button 16 in the horizontal direction. To be specific, thetorsion spring 21 is moved in the horizontal direction in the measuringdevice 11 by sliding the adjustment button 16 in the horizontaldirection, thereby to adjust the spring force. Alternatively, thedistance between the connector receiver 19 that is engaged with the pushbutton 14, and-the spring stopper 23 is increased or reduced by drivinga mechanism (not shown) for converting the motion of the adjustmentbutton 16 in the horizontal direction into the to-and-fro motion of thespring stopper 23 along the driving direction of the lancet 2. Theamount of projection can be displayed on the display unit 12 byconverting the amount of sliding of the adjustment button 16 to theamount of projection using a CPU or the like of the measuring device.

[0193] The patient drops a small amount of blood that is oozing from thelanced fingertip, onto the front end of the sensor 10, and the droppedblood is drawn into the cavity 5 by capillary phenomenon. The measuringdevice 11 measures blood sugar with the internal electronic circuit, anddisplays the result on the display unit 12. When the result ofmeasurement is displayed to end the measurement, the patient slides theslide button 15 in the direction toward which the lancet 2 projects,whereby the lancet-integrated sensor is ejected from the measuringdevice 11, and the ejected lancet-integrated sensor is disposed of.

[0194] At this point of time, the connector 2 b of the lancet 2 isengaged with the connector receiver 19 of the measuring device 11although the ejection lever 22 pushes the rear end of the sensor 1.Since the sensor 1 is ejected firstly, the positional relationshipbetween the sensor 1 and the lancet 2 goes into the state shown in FIG.2(d). Then, the fine projection 2 c of the lancet 2 is engaged with theconcave groove 60 a, and the lancet-integrated sensor is ejected fromthe measuring device 11 with the needle tip of the lancet 2 beingcompletely housed in the sensor 1. Therefore, it is possible to preventinjury or infectious disease caused by that the needle tip protrudesfrom the sensor.

[0195] As described above, according to the first embodiment of theinvention, since the sensor and the lancet are integrated with eachother, management thereof is facilitated, and the trouble of separatelyreplacing the sensor and the lancet at every use is saved. Further,since the sensor and the lancet can be simultaneously set in themeasuring device, setting is facilitated, and the whole unit is reducedin size and easy to carry.

[0196] When the lancet-integrated sensor is ejected, in order to preventinjury and infectious disease more reliably, a semi-circular space thatconforms to the shape of the front end of the sensor 1 is formed on aside of the grip part 3 a of the protection cover 3 as shown in FIG.6(a), and the lancet-integrated sensor may be ejected with the sensor 1being covered with the protection cover 3 as shown in FIG. 6(b).

[0197] Further, while the lancet-integrated sensor according to thefirst embodiment is provided with the protection cover that covers thetip of the lancet, the lancet-integrated sensor may be provided with aholder which covers the periphery of the lancet-integrated sensor andthe protection cover to hold them. In this case, fitting of thelancet-integrated sensor to the measuring device and ejection of thesensor from the measuring device can be carried out with the sensorbeing covered with the holder, and the operation is eased for patientswith manual impairments.

[0198] When the holder is formed of a transparent material to make iteasy to see the internal lancet-integrated sensor, the operability isfurther enhanced.

[0199] Furthermore, while in the first embodiment the lancet-integratedsensor uses the space in which the needle tip of the lancet moves, alsoas the cavity into which blood is drawn, the space and the cavity may beseparated. Further, while in this first embodiment the sensor is a thinplate in shape, the shape of the sensor is not restricted thereto, andthe sensor may be cylindrical in shape.

[0200] Furthermore, as shown in FIG. 7, the slide button 15 of themeasuring device 11 may have wave-shaped projections and depressions onits upper surface to prevent the finger from slipping, and the shape ofthe sensor insertion slot 13 may be approached to rectangle.

[0201] (Embodiment 2)

[0202] According to a second embodiment of the invention, when thelancet-integrated sensor is disconnected from the measuring device, thetip of the needle 2 a is reliably housed in the sensor to prevent thepossibility that a finger of another person touches the needle 2 a ontowhich the bodily fluid remains, or a person pricks his/her finger withthe needle 2 a.by mistake, thereby avoiding infectious disease as wellas problems in terms of safety. This second embodiment corresponds toclaims 32 to 37.

[0203] Hereinafter, a description will be given of a lancet-integratedsensor, and a measuring device which performs a measurement using thelancet-integrated sensor.

[0204]FIG. 8(a) is a perspective view illustrating an example of alancet-integrated sensor according to the second embodiment of theinvention.

[0205] With reference to FIG. 8(a), reference numeral 2 denotes a lancetfor lancing the skin of a man or an animal to extract bodily fluid. Thelancet 2 is composed of a connector 2 b which is made of anapproximately rectangle-shaped plate member, and a needle 2 a forlancing the skin, which is provided at the head of the connector 2 b,i.e., in the vicinity of the center of a semi-circular-shaped shorterside of the connector 2 b having two shorter sides. In the vicinity ofthe center of two longer sides of the connector 2 b, small-sized fineprojections 2 c are formed at right angles from the respective longersides, and these fine projections 2 c have, on their upper surfaces,fine concave portions 21 a and 21 b (concave portions for locking,locking members) which are somewhat long from side to side and havesemi-cylindrical-shaped bottom surfaces. Reference numeral 1 denotes asensor for analyzing the extracted bodily fluid. The sensor 1 has aninternal cavity 1 a in which the lancet 2 is slidably housed. The sensor1 has, at the ceiling of the cavity 1 a, fine convex portions 61 a and61 b (convex portions for locking, locking members) which are somewhatlong from side to side and have semi-cylindrical-shaped surfaces, to beengaged with the fine concave portions 21 a and 21 b provided on thefine projections 2 c of the lancet 2, respectively. Reference numeral 1a denotes a cavity formed in the sensor 1. The cavity 1 a has a width alittle larger than the width of the lancet 2, and has a pair of concavegrooves 60 a that project from two longer sides of the cavity 1 a, inthe width direction, correspondingly to the fine projections 2 c of thelancet 2. Reference numeral 2 a denotes a needle for lancing the skin,which is provided at a front end 2 e of the lancet 2, i.e., in thevicinity of the center of a somewhat-rounded shorter side (head side) oftwo shorter sides of the lancet 2. Reference numeral 10 denotes alancet-integrated sensor, in which the lancet 2 and the sensor 1 areintegrated with each other.

[0206]FIG. 8(b) is an exploded perspective view illustrating an exampleof a lancet-integrated sensor according to the second embodiment of theinvention.

[0207] As shown in FIG. 8(b), the lancet-integrated sensor 10 isconstituted by placing the lancet 2 between a cover 6 and a substrate 7which are components of the sensor 1, and bonding the cover 6 and thesubstrate 7 together.

[0208] The cover 6 has a groove 6 a whose outline shape is a littlelarger than the lancet 2, and the groove 6 a forms a cavity 1 a in whichthe lancet 2 is to be housed slidably along its longitudinal direction.In the groove 6 a, concave grooves 60 a for restricting a region wherethe lancet 2 is slidable are formed on the rear of the longer sides ofthe groove 6 a so that a part with the concave grooves 60 a becomes alittle wider than the other part of the groove 6 a, and the length ofeach concave groove 60 a in the transverse direction is set according tothe length of the fine projection 2 c of the lancet 2.

[0209] Further, as described above, the fine concave portions(projections) 21 a and 21 b of the lancet 2 are formed on the uppersurfaces of the fine projections 2 c which are formed in the vicinity ofthe center of the longer sides of the lancet 2, in positions mostdistant from the needle 2 a, i.e., in the vicinity of the edges of theprojections 2 c on the opposite side from the needle 2 a. The fineconvex portions 61 a and 61 b of the sensor 1 are formed in the ceilingsof the concave grooves (hollows) 60 a of the cover 6, in positions mostdistant from the needle 2 a when the lancet-integrated sensor isassembled, i.e., in the vicinity of the edges of the concave grooves 60a on the opposite side from the needle 2 a.

[0210] Although the positional relationship between the fine concaveportions 21 a and 21 b and the fine convex portions 61 a and 61 b may beother than mentioned above, these portions must be arranged with apredetermined positional relationship such that the needle 2 a of thelancet 2 is housed in the sensor 1 when the fine concave portions 21 aand 21 b of the lancet 1 are engaged with the fine convex portions 61 aand 61 b of the concave grooves 60 a of the cover 6.

[0211] Further, the front end of the cover 6, i.e., the shorter side ofthe cover 6 facing the needle 2 a of the lancet 2, is semi-circular inshape, and a groove 6 b an end of which is connected to the groove 6 ais formed at the front end of the cover 6 so that the needle 2 a at thefront end 2 e projects from the sensor 1, and the other end of theconnecting groove 6 b is an opening 6 d of the front end of the sensor1. An opening 6 c is also formed on the rear end of the cover 6, i.e.,an end of the cover 6 on the side opposite to the needle 2 a of thelancet 2, so that the connector 2 b of the lancet 2 projects from thesensor 1, and notches 21 a and 21 b are formed at two corners of therear end of the cover 6 so that the electrodes 4 are exposed.

[0212] Although the front end of the substrate 7 is semi-circular inshape like the cover 6, the substrate 7 has no notches on the the rearend unlike the cover 6. On the surface of the substrate 7, two electrodeterminals 4 are formed at the two corners of the rear ends of the longersides, and a pair of electrodes 8 connected to the electrode terminals 4by wiring are formed in the vicinity of the center of the semi-circularpart on the front end of the substrate 7. Further, a reagent layer (notshown) is formed on the surface of the electrodes 8. Thelancet-integrated sensor 10 is completed by bonding the cover 6 to thesubstrate 7, with the lancet 2 being housed in the groove 6 a of thecover 6 as described above.

[0213] A protection cover 3 is fitted to the lancet-integrated sensoraccording to the second embodiment of the invention as shown in FIGS.2(a) and 2(b). Further, the measuring device for the lancet-integratedsensor according to the second embodiment of the invention has the sameoutward shape as that shown in FIG. 3. The internal structure of themeasuring device is the same as that shown in FIGS. 4(a) and 4(b) andFIGS. 5(a), 5(b), and 5(c).

[0214] Next, a series of measuring operations of the lancet-integratedsensor and the measuring device which are completed as described above,will be described.

[0215] Initially, an operation of attaching the lancet-integrated sensorto the measuring device will be described. In the state where thelancet-integrated sensor is not used, the lancet 2 is placed in such aposition that the needle tip projects from the sensor 1, and the needletip is covered with the protection cover 3, as shown in FIG. 2(a). Theprotection cover 3 is composed of a tube 3 b as a needle housing part,and an approximately-square-shaped grip part 3 a. The user holds thewide grip part 3 a of the protection cover 3, and inserts the rear endof the connector 2 b of the lancet 2 (the end of the lancet 2 oppositeto the needle) from the opening 13 a of the insertion slot 13 of themeasuring device 11, as shown in FIG. 2(a).

[0216] At this time, as shown in FIG. 5(a), the rear end of theconnector 2 b of the lancet 2 is guided by the guide (guide member) 17in the measuring device 11, and goes toward the concave portion 19 a ofthe front end of the connector receiver 19. The connector receiver(lancet pushing member) 19 is pressed in opposite directions by the coilspring 18 and the torsion spring 21, and stands still in the positionwhere the pressing forces are balanced.

[0217] As the user continues to insert the lancet-integrated sensor 10with the lancet 2 being covered with the protection cover 3, initiallythe lancet 2 is gradually inserted together with the sensor 1 to reachthe position where it contacts the ejection lever 15 that is united withthe slide button 14. Thereafter, when the slide button 14 reaches theend of its movable range (display 13 side) that is restricted by thetermination member 17 a of the guide 17, the sensor 1 stops its backwardmovement. On the other hand, the lancet 2 moves back in the sensor 1while the user pushes the protection cover 3.

[0218] When the lancet 2 reaches an end of its movable range in thesensor 1, the fine concave portions 21 a and 21 b of the lancet 2 areengaged with the fine convex portions 61 a.and 61 b of the cover 6 ofthe sensor 1 as shown in FIG. 2(b), whereby the lancet 2 is locked withrespect to the sensor 1. At this time, the rear end of the lancet 2 isengaged with the concave portion 19 a of the connector receiver 19, andthe connector receiver 19 moves back as the user continues to push theprotection cover 3, and the tapered projection 20 a of the driving lever20 that is fixed to the connector receiver 19 is engaged with thetapered projection 11 a that is provided at the ceiling in the measuringdevice 11 as shown in FIG. 5(b), whereby the connector receiver 19 islocked. In this state, attachment of the lancet-integrated sensor 10 tothe measuring device 11 is completed.

[0219] Next, a blood collecting operation and a blood dropping operationwill be described. When attachment of the lancet-integrated sensor tothe measuring device is completed, the vicinity of the semi-circularhead portion of the sensor 10 is slightly exposed from the holder 13 asshown in FIG. 3(a). The user holds the measuring device 11, and lightlypresses the front end of the sensor 10 against a portion of his/her bodyfrom which blood is to be extracted, such as a fingertip.

[0220] When the user pushes the push button (unlocking member) 14, thetapered projection 20 a of the driving lever 20 and the taperedprojection lic of the measuring device 11 are disengaged from eachother, and the lancet 2 and the sensor 1 are unlocked by extension ofthe coil spring 18, whereby the lancet 2 is driven (refer to FIG. 10)and, as shown in FIG. 2(c), the needle tip projects from the front endof the sensor 1 to lance the skin. At this time, the amount ofprojection of the needle tip from the sensor is variable by theadjustment button 16 shown in FIG. 3(b). To be specific, the torsionspring 21 is moved in the horizontal direction in the measuring device11 by sliding the adjustment button 16 in the horizontal direction,thereby to adjust the spring force. Alternatively, the distance betweenthe connector receiver 19 that is engaged with the push button 14, andthe spring stopper 23 is increased or reduced by driving a mechanism(not shown) for converting the motion of the adjustment button 16 in thehorizontal direction into the to-and-fro motion of the spring stopper 23along the driving direction of the lancet 2. The amount of projectioncan be displayed on the display unit 12 by converting the amount ofsliding of the adjustment button 16 to the amount of projection, withthe CPU or the like of the measuring device.

[0221] A small amount of blood that is oozing from the lanced fingertipof a patient or a person being tested is dropped onto the front end ofthe sensor 1, and the blood is drawn into the cavity 5. The measuringdevice 11 measures blood sugar by the internal electronic circuit, anddisplays the result on the display unit 12. When the result ofmeasurement is displayed to complete the measurement, the user operatesthe slide button (ejection member) 15 to eject the lancet-integratedsensor 10 from the measuring device 11, and the ejectedlancet-integrated sensor 10 is disposed of.

[0222] At this time, the ejection lever (ejection member) 22 that isunited with the slide button 15 pushes the sensor 1 from its rear end.At the beginning of pushing, the connector 2 b at the rear end of thelancet 2 is engaged with the concave portion 19 a of the connectorreceiver 19 of the measuring device 11. Therefore, the sensor 1 isejected before the lancet 2 by operating the slide button 15.Accordingly, the positional relationship between the sensor 1 and thelancet 2 becomes as shown in FIG. 5(b). That is, the fine concaveportions 21 a and 21 b of the lancet 2 are engaged with the fine convexportions 61 a and 61 b of the concave grooves 60 a and 60 b of thesensor 1, and the lancet 2 is locked in the state where its needle tipdoes not project from the sensor 1. When the slide button 14 is furtherpushed, the lancet 2 with the needle tip 2 a being locked in the sensor1 is ejected together with the sensor 1 from the measuring device 11.Therefore, the needle 2 a of the lancet 2 is not exposed from the sensor1, thereby preventing injury or infectious disease caused by the needletip being exposed.

[0223] As described above, according to the second embodiment of theinvention, the lancet-integrated sensor is ejected in the state wherethe lancet 2 and the sensor 1 are reliably locked with each other. Atthis time, the lancet 2 and the sensor 1 are locked with the needle 2 aof the lancet 2 being housed in the sensor 1. Therefore, when taking thelancet-integrated sensor 10 out of the measuring device, there is nopossibility that the user touches the needle 2 a of the lancet 2 withhis/her finger, or pricks the finger with the needle 2 a by mistake,thereby preventing infectious diseases. As a result, a lancet-integratedsensor which can be safely ejected from the measuring device isobtained.

[0224] Furthermore, it is possible to obtain a measuring device for alancet-integrated sensor, which can measure bodily fluid with such asafely-detachable lanced-integrated sensor, and can eject thelancet-integrated sensor with the lancet being locked in the state wherethe needle of the lancet is housed in the sensor, when measurement isended.

[0225] While in this second embodiment a concave portion is provided onthe upper surface of the lancet and a convex portion that is engagedwith the concave portion is provided on the sensor 2, the positionswhere the concave portion and convex portion are provided may bearbitrarily set as long as the lancet and the sensor are locked byengagement of the concave portion with the convex portion after end ofmeasurement, and the needle of the lance is housed in the sensor.

[0226] (Embodiment 3)

[0227] According to a third embodiment of the present invention, aholder for guiding the lancet-integrated sensor into the measuringdevice is detachable from the measuring device to enable cleaning or thelike of the holder, and this embodiment corresponds to inventions ofclaims 38 to 43.

[0228] To be specific, when a patient extracts bodily fluid using themeasuring device with the lancet-integrated sensor according to thefirst or second embodiment, the patient must apply his/her finger orupper arm to the holder-shaped insertion slot 13 of the measuring device11 to lance the skin, and the bodily fluid of the patient sometimessticks to the insertion slot 13 of the measuring device 11.

[0229] However, since, in the measuring device according to the first orsecond embodiment, the measuring device 1 is united with the insertionslot 13, the insertion slot 13 cannot be cleaned or replaced after themeasurement. Therefore, if another patient performs measurement with themeasuring device in which the other's bodily fluid remains on theinsertion slot 13, the bodily fluid of the patient might contact theother's bodily fluid, resulting in the fear of infectious diseases orthe like. Accordingly, the measuring device of the first or secondembodiment can be used for personal measurement only.

[0230] On the other hand, the measuring device for the lancet-integratedsensor according to the third embodiment enables the user to clean orreplace the insertion-slot-shaped holder to which the bodily fluidsticks, whereby the user can handle the measuring device safely andcleanly.

[0231]FIGS. 11 and 12 are diagrams illustrating the construction of themeasuring device for the lancet-integrated sensor, according to thethird embodiment of the invention.

[0232] In FIG. 11, FIG. 11(a) is a perspective view of alancet-integrated sensor and a measuring device to be combined with thesensor, and FIG. 11(b) shows the state when a holder is disconnected.

[0233] In FIG. 11, reference numeral 11 denotes a measuring device for alancet-integrated sensor (hereinafter referred to as a measuring device)for measuring blood sugar or the like with a lancet-integrated sensor 2that is fitted to it, and reference numeral 10 denotes alancet-integrated sensor.

[0234] The measuring device 11 has a holder attachment part 47 on a sidewall where the lancet lances the skin, and a holder body 43 for holdingan end portion of the lancet-integrated sensor 10 in the vicinity of theside where the lancet lances the skin is detachably attached to theholder attachment part 47. Further, the measuring device 11 has anoperation button 14 for driving the lancet that is fitted to it, adisplay 12 for displaying the measurement result or the like, a slidebutton 15 for ejecting the lancet-integrated sensor 10 from themeasuring device 11, and a holder attachment part 47 to which the holderbody 43 is attached.

[0235] As shown in FIG. 11(b), the holder body 43 is detachable from themeasuring device 11 so that the bodily fluid that sticks to the holderbody 43 can be washed away or the holder body 43 can be replaced withanother one after completion of measurement.

[0236] Further, as already described above, the lancet-integrated sensor10 is constituted by integrating the lancet 2 for lancing the skin of aman or an animal to extract bodily fluid, and the sensor 1 for analyzingthe extracted bodily fluid.

[0237] Hereinafter, the constructions of the holder body 43 and theholder attachment part 47 will be described in more detail, withreference to FIG. 12.

[0238]FIG. 12 is a diagram for explaining attachment/detachment of theholder body 43 to/from the holder attachment part 47.

[0239] With reference to FIG. 12(a), reference numerals 43 a and 43 bdenote hinge-shaped stoppers possessed by the holder body 43. Thesestoppers are formed by bending plate members, which are extended forwardfrom the both ends of the holder body 43, i.e., in the directionopposite to the direction along which the lancet-integrated sensor isinserted, backward at approximately 180°. The stoppers 43 a and 43 bhave, at their front ends, clip parts 43 e and 43 f which serve asretainers of the stoppers 43 a and 43 b, and perform positioning whenthe holder body 43 is stopped at the opening 47 c, respectively. Theinner sides of the hinge-shaped stoppers are fixed onto the holder body43, and the outer sides of the hinge-shaped stoppers are engaged withengagement parts of the holder attachment part 47, whereby the holderbody 43 is stopped by connecting it to the measuring device 11. That is,the holder body 43 is stopped, with its spring force, at holes (smallopenings) 47 a and 47 b which are formed at two shorter sides of theholder attachment part 47 having an opening shape approximately equal tothe outer shape of the holder body 43 so as to increase the width of theholder attachment part 47 to some extent. The holes. 47 a and 47 b maybe formed at two longer sides of the opening 47 a of theapproximately-rectangle holder attachment part 47.

[0240] The holder body 43 can be attached to the holder attachment part47 of the measuring device 11 by inserting the stoppers 43 a and 43 b ofthe holder body 43 into the holes 47 b and 47 b of the holder attachmentpart 47, respectively. As shown in FIG. 12(a), the holes 47 a and 47 bof the holder attachment part 47 have different sizes and the stoppers43 a and 43 b of the holder body 43 have different sizes, whereby theholder body 43 cannot be inserted upside down. The reason is as follows.If the lancet-integrated sensor 10 is inserted upside down into themeasuring device 11, electrical connection between the lancet-integratedsensor 10 and the measuring device 11 cannot be made. In order to avoidthis problem, the right and left holes of the holder attachment part 47are formed in different shapes and the right and left stoppers of theholder body 43 are also formed in different shapes, so that the holderbody 43 can be inserted into the holder attachment part 47 only when itsup-to-down direction is a certain direction, i.e., a normal direction,whereby the lancet-integrated sensor 10 cannot be inserted upside down.

[0241]FIG. 12(b) and FIG. 12(c) are cross-sectional views in the casewhere the holder body 43 is stopped by connecting it to the measuringdevice 11. FIG. 12(b) shows the state where the hinge-shaped stoppers 43a and 43 b of the holder body 43 are engaged with the holes 47 a and 47b of the measuring device 11. Further, FIG. 12(c) shows the state wherethe user tries to detach the holder body 43 by pressing the clipportions 43 e and 43 f of the stoppers 43 a and 43 b with fingers toreplace the holder body 43, after measurement is completed or whenanother person uses the measuring device 11.

[0242] Since the holder for attaching the lancet-integrated sensor,which is possessed by the measuring device, is detachable as describedabove, the holder body onto which bodily fluid sticks can be replacedwith an unused one or washed, whereby the measuring device can be usednot only by a specific user but also by anyone other than the user,without the fear of infectious diseases or the like. Therefore, themeasuring device for the lancet-integrated sensor can be used safely andcleanly.

[0243] Further, since the holder body is provided with the hinge-shapedstoppers to be engaged with the holder attachment part, fixation andattachment/detachment of the holder body can easily carried out.

[0244] Furthermore, since the holes of the holder attachment part havedifferent shapes and the stoppers of the holder body also have differentshapes, the holder body can always be attached in the normal directionto the measuring device, thereby preventing the lancet-integrated sensorfrom being inserted upside down into the measuring device.

[0245] While in this third embodiment the shapes of the left and rightstoppers 43 a and 43 b of the holder body 43 are different from eachother and the shapes of the left and right holes 47 a and 47 b of theholder attachment part 47 are also different from each other, theseengagement parts of the holder body and the holder attachment part mayhave arbitrary shapes as long as the respective engagement parts areasymmetrical in the vertical or horizontal direction so that the holderbody can be attached to the holder attachment part only when the holderbody is inserted in a predetermined direction.

[0246] Furthermore, the spring stopper 23 of the measuring device 11 maybe fixed to the ceiling of the measuring device 11 as shown in FIG.13(a), and the coil spring 18 may be attached to a shaft 56 a that isfixed onto the spring stopper 23.

[0247] Furthermore, the lancet-integrated sensor 10 may have a shapethat is a little shorter in the longitudinal direction as shown in FIG.13(b).

[0248] (Embodiment 4)

[0249] According to a fourth embodiment of the present invention, theamount of projection of the needle tip from the lancet-integratedbiosensor can be easily adjusted. Further, when the lancet is driven soas to project out forcibly, if the drive is stopped halfway due to sometrouble, the lancet can easily be returned to the state before beingdriven. This fourth embodiment corresponds to the inventions of claims53 to 58.

[0250] To be specific, in the measuring device for the lancet integratedsensor according to the first or second embodiment, when extraction ofbodily fluid is carried out, the driving means 100 is operated bypushing down the operation button 14 to drive the lancet 2 so that theneedle 2 a lances a fingertip or upper arm, and the extracted blood isdropped onto the sensor 1 to perform measurement of it. However, whenextraction of bodily fluid cannot be carried out due to some troublesuch as insufficient lancing of the lancet, the lancet 2 must be resetto the state where the lancet 2 can be driven again.

[0251] However, in order to reset the once driven lancet 2 to the statewhere it can be driven again, the lancet-integrated sensor 10 must beonce ejected by using the slide button 15 and, thereafter, reattached tothe measuring device 11. It is sometimes necessary to replace thelancet-integrated sensor 10 itself.

[0252] Further, since the lancet-integrated sensor according to thefirst or second embodiment is not provided with an effective means foradjusting the amount of projection of the needle tip of the lancet, itis difficult to adjust the amount of bodily fluid oozing from thepatient or reduce pain of the patient.

[0253] On the other hand, the measuring device for the lancet-integratedsensor according to the fourth embodiment can easily adjust the amountof projection of the needle tip of the lancet, and it can performre-preparation for measurement when bodily fluid cannot be extracted dueto some trouble such as insufficient lancing of the lancet.

[0254] Hereinafter, the measuring device for the lancet-integratedsensor according to the fourth embodiment will be described.

[0255]FIG. 14 is a diagram illustrating an example of the measuringdevice according to the fourth embodiment of the present invention.

[0256] With reference to FIG. 14, reference numeral 11 denotes ameasuring device for a lancet-integrated sensor (hereinafter referred toas a measuring device) according to the fourth embodiment of theinvention. Reference numeral 13 denotes an insertion slot into which thelancet-integrated sensor is inserted, and the insertion slot is appliedto a finger or upper arm of a patient when measurement is carried out;numeral 14 denotes an operation button for driving the lancet that isfitted to the measuring device 11; numeral 12 denotes a display fordisplaying the result of measurement or the like; numeral 15 denotes aslide button for ejecting the lancet-integrated sensor from themeasuring device 11; numeral 56 denotes a pull stick for returning thelancet-integrated sensor back to the stand-by position where measurementcan be performed with the lancet-integrated sensor being fitted to themeasuring device 11, by pulling the lancet-integrated sensor in thedirection opposite to the lancet driving direction, i.e., in thedirection shown by an arrow A in FIG. 14, when some trouble occurs inextracting bodily fluid; and numeral 57 denotes a lancet projectionamount adjuster for adjusting the amount of projection of the needle tipof the lancet, which also serves as a stopper of the pull stick 56.

[0257]FIG. 15 is a cross-sectional view taken along a line X-X′, of themeasuring device for the lancet-integrated sensor shown in FIG. 14. InFIG. 15, the pull stick 56 has a handle part 56 d. The same constituentsas those described with respect to FIG. 14 are given the same referencenumerals to omit description thereof.

[0258] In FIG. 15, reference numeral 10 denotes a lancet-integratedsensor fitted to the measuring device 11, which is constituted byintegrating the lancet 2 for lancing the skin of a man or an animal toextract bodily fluid, and the sensor 1 for analyzing the extractedbodily fluid.

[0259] Further, reference numeral 19 denotes a connector receiver havinga concave portion 19 a that is engaged with a connector 2 b possessed bythe lancet 2 as a component of the lancet-integrated sensor 10.Reference numeral 56 a denotes a shaft, and the connector receiver 19for receiving an end of the lancet 2, which end is opposed to the sidewhere the skin is lanced, is fixed to an end of the shaft 56 a, whichend is opposite to the side where the skin is lanced. An end (slip-outprevention member) 56 b of the shaft 56 a, which is positioned withinthe pull stick 56, has a diameter larger than the diameter of an opening56 c of the pull stick 56. Reference numeral 20 denotes a driving leverwhich is provided on the connector receiver 19, and the driving lever 20stops the move of the connector receiver 19 against a force by which theconnector receiver 19 is moved in the direction along which the lancet 2lances the skin, by the spring 18 which is fitted to the shaft 56 a thatis unlocked by pressing the operation button 14 for starting theoperation of the driving means 100. The operation button 14, the pullstick 56, the lancet projection amount adjuster 57, the shaft 56 a, andthe connector receiver 19 constitute the driving means 100 which drivesthe lancet 2 from its stand-by position along the longitudinal directionof the sensor 1, i.e., the direction along which it lances the skin and,thereafter, returns the lancet back to the stand-by position, with thelancet-integrated sensor 10 being fitted to the measuring device 11.

[0260] Next, the operation will be described.

[0261] First of all, the patient pushes the lancet-integrated sensor 10into the sensor insertion slot 13 of the measuring device 11, wherebythe connector 2 b possessed by the lancet 2 of the lancet-integratedsensor 10 is engaged with the concave portion 19 a of the connectorreceiver 19, and a tapered projection (claw portion) 20 a of the drivinglever 20 fixed to the connector receiver 19 is engaged with a taperedprojection (claw portion) 11 c of the measuring device 11 so that thelancet 2 can be shot by pressing down the operation button 14.

[0262] Thereafter, the patient applies the insertion slot 13 of themeasuring device 11 to his/her finger or upper arm, and presses theoperation button 14, whereby the tapered projection 20 a of theconnector receiver 19 is disengaged from the tapered projection 11 c ofthe measuring device 11, and the lancet 2 is shot from the tip of thecenter 10.

[0263] At this time, if the lancet 2 fails to lance the skin ormeasurement does not go well due to some trouble, the user picks thepull stick 56 and pulls it in the direction of the arrow shown in FIG.14, i.e., upward in the figure, whereby the end 56 b of the shaft 56 ais pulled up, and the connector receiver 19 holding the connector 2 b ofthe lancet 2 is operated in synchronization with the shaft 56 a. Thus,the tapered projection 20 a provided on the connector receiver 19 can bere-engaged with the tapered projection lic just before the operationbutton 14.

[0264] Further, when the lancet 2 is shot, the lancet 2 moves along thelongitudinal direction of the sensor 1, and the pull stick 56 that isoperated in synchronization with the lancet 1 moves until reaching theopposed surface of the lancet projection amount adjuster 57. The lancetprojection amount adjuster 57, which serves as a stopper for the pullstick 56, has a structure of a screw thread to be screwed into a screwhole lid that is formed on a side of the measuring device 11 opposite tothe insertion slot 13. The lancet projection amount adjuster 57 can bemoved along the lancet moving direction by rotating it clockwise orcounterclockwise.

[0265] Therefore, the measurer adjusts the position of the lancetprojection amount adjuster 57 in advance of driving the lancet 2, andadjusts the spring force by adjusting the distance between the connectorreceiver 19 and the spring stopper (supporting member) 23, therebysetting the amount of projection of the needle 2 a of the lancet 2 to adesired amount. Thus, the shot lancet 2 moves until the pull stick 56hits the lancet projection amount adjuster 57 to stop, whereby theamount of projection of the needle tip of the lancet 2 from the sensorcan be adjusted.

[0266] As described above, according to the fourth embodiment, even whenthe lancet 2 fails to lance the skin or measurement does not go well dueto some trouble, preparation for re-measurement can be easily carriedout using the pull stick 56 which set the connector receiver 19 holdingthe connector 2 b of the lancet 2, beneath the operation button 14 againto bring the measuring device into the state where measurement can becarried out.

[0267] Furthermore, since the measuring device 11 is provided with thelancet projection amount adjuster which can adjust the mount ofprojection of the lancet, the amount of bodily fluid oozing from thepatient can be adjusted, or pain of the patient can be reduced.

[0268] (Embodiment 5)

[0269] A fifth embodiment according to the present invention provides abiosensor cartridge, by which a biosensor or a lancet-integrated sensorcan be fitted to a measuring device without a troublesome operation.This fifth embodiment corresponds to claims 44 to 52.

[0270] Hereinafter, a biosensor cartridge according to the fifthembodiment of the invention will be described taking, as an example, acartridge which houses biosensors for electrochemically measuring bloodsugar, with reference to the drawings.

[0271]FIG. 16 is a diagram illustrating a biosensor cartridge accordingto the fifth embodiment of the invention.

[0272] In FIG. 16, reference numeral 1 denotes biosensors for measuringblood sugar, and each biosensor 1 is formed of a plate member that isapproximately rectangle in shape, and one of two shorter sides of therectangle biosensor 1 is semi-circular in shape. Reference numeral 11denotes a measuring device for measuring blood sugar with the biosensor1 attached thereto. Reference numeral 63 denotes a biosensor cartridgecomprising plastic or the like, and the cartridge 63 has anapproximately-rectangular-parallelepiped housing box (cartridge body) 63c, and plural housing sections 63 b which are slits each conforming tothe shape of the biosensor 1. The housing sections 63 b can hold pluralbiosensors 1 separately, by perpendicularly supporting the biosensors 1with their end portions to be inserted into the measuring device 11turning up. The spacing between the housing sections (slits) 63 b forhousing the biosensors 1 should be sufficiently large so that theinsertion slot 11 a of the measuring device 11 can be pressed onto oneof the separately housed biosensors 1. That is, when inserting a targetbiosensor 1 into the insertion slot 11 a of the measuring device 11,this spacing prevents the insertion slot 11 a from contacting thebiosensors adjacent to the target biosensor. Reference numeral 63 adenotes a lid (lid part) of the biosensor cartridge 63. The lid 63 a ishollow and approximately rectangular-parallelepiped in shape, and thelid 63 a is opened or closed by rotating it at about 90 degrees about ahinge 63 h that is provided on a side of the housing box 63 c.

[0273]FIG. 17 is a diagram illustrating the state where one of thebiosensors housed in the biosensor cartridge of the fifth embodiment isinserted into the measuring device.

[0274] Attachment of the biosensor 1 to the measuring device 11 iscarried out as follows. After the lid 63 a of the biosensor cartridge 63is opened as shown in FIG. 16, the biosensor 1, which is stored in thebiosensor cartridge 63 with its semi-circular end turning up, isinserted into the biosensor insertion slot 11 a of the measuring device11 as shown in FIGS. 17(a) and 17(b).

[0275] At this time, the spacing between the housing sections 63 b forhousing the biosensors 1 is set so that, when a target biosensor 1 isinserted into the insertion slot 11 a of the measuring device 11, theinsertion slot 11 a does not contact the biosensors adjacent to thetarget biosensor. Therefore, the target biosensor 1 can beeasily.-attached to the measuring device 11 without damaging otherbiosensors 1.

[0276] As described above, according to the biosensor cartridge of thefifth embodiment, the spacing between the respective housing sectionsprovided in the biosensor cartridge is sufficiently large so that one ofthe separately stored biosensors 1 can be inserted into the insertionslot 11 a of the measuring device 11. Therefore, the biosensor 1 can beinserted into the measuring device 11 with a single touch, wherebypreparation for measurement can be easily carried out. Consequently, oneof the biosensors stored in the cartridge can be inserted into themeasuring device 11 without a troublesome operation, and it is possibleto minimize such accident that the insertion slot 11 a of the measuringdevice contacts the biosensors adjacent to the target biosensor therebyto damage the biosensors.

[0277] (Modification 1 of Embodiment 5)

[0278] Hereinafter, a biosensor cartridge according to a firstmodification of the fifth embodiment will be described. The biosensorcartridge according to this first modification is characterized in themanner of hermetically sealing the cartridge. Since other constituentsare identical to those described for the fifth embodiment, the samereference numerals are given to the constituents to omit descriptionthereof.

[0279]FIG. 18 is a diagram illustrating a biosensor cartridge accordingto the first modification of the fifth embodiment.

[0280] As shown in FIG. 18(a), in: the biosensor cartridge 63, anapproximately-rectangular-parallelepiped lid 63 a having a hollow insideis rotatably fixed onto an approximately-rectangular-parallelepipedhousing box 63 c with a hinge whose rotation axis is slidable in thelongitudinal direction of the lid 63 a.

[0281] The hinge is composed of a pair of axial projections 63 gwhichproject in the vertical direction with respect to the side surfacesforming the longer sides of the lid 63 a from the vicinities of the bothends of the shorter side of the opening of the lid 63 a; aside-to-side-long bearing 63 i which extends within the same plane asthe side surfaces along the longer sides of the opening of the housingbox 63 c from the vicinities of the both ends of the shorter side of theopening; and a bearing hole 63 iwhich is formed in the bearing 63 i inan oval shape, with which the axial projections 63 g are engaged.

[0282] Then, four reverse-L-shaped projections 63 d which are formed atthe edges of the respective sides of the opening of the lid 63 a arepositioned at four notches 63 e formed in an projection part (peripheraledge part) 63 f which is formed at the edges of the respective sides ofthe upper surface of the housing box 63 c of the biosensor cartridge 63,and the projections 63 d are crawled into the notches 63 e. Then, thelid 63 a is rotated at 90° in the direction indicated by an arrow (i.e.,counterclockwise) and, thereafter, slightly slid in the radial direction(i.e., left forward direction in the figure), whereby the L-shapedprojections 63 d are engaged with the projection part 63 f in thevicinity of the notches 63 e, and the lid 63 a seals the housing box 63c having the plural housing slits, of the biosensor cartridge 63. FIG.18(b) is a side view illustrating the state where the housing box issealed with the lid, from the state shown in FIG. 18(a).

[0283] Further, FIG. 18(c) is a cross-sectional view illustrating thestate where an elastic member (sealing member) 64 is disposed on thepart where the housing box 63 c and the lid 63 a are closely contactwith each other (i.e., on the peripheral edge part of the opening of thelid 63 a) to hermetically seal the container. The elastic member 64 is amember having a large elasticity such as rubber. In this way, thehermeticity of the biosensor cartridge can be increased by integrallyforming the elastic member 64.

[0284] Although the shape of the biosensor housing part is notparticularly described above, plural slits, each conforming to the shapeof the biosensor, may be formed at regular intervals in the member thatfills the concave portion of theapproximately-rectangular-parallelepiped housing box 63 c. Thereby, thebiosensors can be perpendicularly supported at regular intervals sothat, when inserting the target biosensor 1 into the insertion slot 2 aof the measuring device 2 as in the fifth embodiment, the insertion slot2 a does not contact the adjacent biosensors.

[0285] As described above, according to the first modification of thefifth embodiment, the elastic member 64 or the like is formed integrallywith the engagement part of the housing box 63 c and the lid 63 a of thebiosensor cartridge 63, and the housing box 63 c is covered with the lid63 a. Thereafter, the L-shaped projections 63 d provided on the lid 63 aare crawled into the notches 63 e of the projection part 63 f of thebiosensor cartridge, and the L-shaped projections 63 d are slid to beengaged with the notches 63 e, thereby hermetically sealing thecontainer. Therefore, the hermeticity of the container is increased, andthe moisture in the container is reduced, whereby the sensor isprevented from being contaminated by the moisture, leading toimprovement in accuracy of the sensor.

[0286] [Modification 2 of Embodiment 5]

[0287]FIG. 19 is a diagram illustrating a biosensor cartridge accordingto a second modification of the fifth embodiment of the presentinvention.

[0288] In FIG. 19, reference numeral 10 denotes a lancet-integratedsensor which is constituted by integrating a lancet for lancing the skinof a man or an animal to extract bodily fluid, and a sensor foranalyzing the extracted bodily fluid; reference numeral 11 denotes ameasuring device for measuring blood sugar or the like with alancet-integrated sensor 5 that is attached thereto; and referencenumeral 63 denotes a biosensor cartridge comprising plastic or the like,which is composed of an-approximately-rectangular-parallelepiped lid 63a and an approximately-rectangular-parallelepiped housing box 63 c. Thehousing box 63 c is provided with lower grooves 630 a, intermediategrooves 630 b, and upper grooves 630 c so as to support thelancet-integrated sensors 10, each having a protection cover (protector)3 on its bottom surface, perpendicularly at regular intervals. To bespecific, the lower grooves 630 a, into which the protection covers 3 ofthe lancet-integrated sensors 10 are inserted to be supported, areformed at the side nearest to the bottom of the member that fills up theconcave portion of the housing box 63 c. The intermediate grooves 630 b,into which portions of the lancet-integrated sensors 10 are inserted tobe supported, are formed above the lower grooves. The upper grooves 630c are formed above the intermediate grooves, and lowermost portions ofthe upper grooves 630 c are a little rounded to increase the widths ofthe grooves, and approximately whole portions thereof are wider than thewidths of the sensors of the lancet-integrated sensors 10. A singlehousing part (groove) 63 b is formed of a lower groove (first groove)630 a, an intermediate groove (second groove) 630 b, and an upper groove(third groove) 630 c which are connected with each other. In the housingbox 63 a, the lancet-integrated sensors 10 are respectively housed inthe plural housing parts 63 b at regular intervals, with the portions tobe inserted to the measuring device 11 turning up.

[0289] The spacing between the housing parts for housing thelancet-integrated sensors should be sufficiently large so that theinsertion slot 11 a of the measuring device 11 can be pressed onto oneof the separately stored lancet-integrated sensors 10. As an example ofthe lancet-integrated sensor, the lancet-integrated sensor which hasalready been described for the first or second embodiment may beemployed.

[0290]FIG. 20(a) is a constitutional diagram for explaining attachmentof a lancet-integrated sensor to a measuring device, and FIG. 20(b) is aperspective view thereof.

[0291]FIG. 20(a) shows a lancet-integrated sensor having a needlestorage part that is a little wider than those shown in FIG. 1 and otherfigures.

[0292] Attachment of the lancet-integrated sensor 10 to the measuringdevice 11 is performed as follows. After the lid 63 a of the biosensorcartridge 63 is opened as shown in FIG. 19, the lancet-integrated sensorinsertion slot 11 a of the measuring device 11 is pressed onto thelancet-integrated sensor 1 that is stored in the biosensor cartridge 63as shown in FIG. 20(b).

[0293] As described above, according to the fifth embodiment, thespacing between the respective storage parts of the biosensor cartridgeis sufficiently large so that the insertion slot 11 a of the measuringdevice 11 can be pressed onto one of the lancet-integrated sensors 10that are stored separately, whereby the lancet-integrated sensor 10 canbe inserted into the measuring device 11 by a single touch, andpreparation for measurement can be easily carried out as compared withthe measuring device for the sensor having no lancet. Therefore, one ofthe biosensors stored in the housing case can be inserted into themeasuring device 11 without performing a troublesome operation, and theinsertion slot 11 a of the measuring device 11 is prevented fromcontacting the biosensors adjacent to the target biosensor thereby todamage the biosensors.

[0294] Although the biosensors are perpendicularly supported in thefirst or second modification of the fifth embodiment, when the height ofthe biosensor cartridge should be reduced, the biosensors may besupported in a slanting direction. Also in this case, the same effectsas mentioned above are achieved by providing biosensor storage parts atregular intervals with which the insertion slot of the measuring devicecan pressed onto the target biosensor without damaging the adjacentbiosensors.

APPLICABILITY IN INDUSTRY

[0295] As described above, according to a lancet-integrated sensor ofthe present invention and a measuring device to be combined with thesensor, a sensor and a lancet are integrated, and a measuring device formeasuring the characteristics of bodily fluid is provided with afunction of driving the lancet. Therefore, as compared with theconventional system comprising a sensor, a lancet, a measuring device,and a lancet device, the number of components is reduced, wherebymanagement is facilitated. Especially, it is not necessary to manage thenumber of disposal sensors and lancets separately. Further, whencarrying these devices, the volume is reduced, resulting in aconvenience of portability.

[0296] Further, when preparing for measurement, it is not necessary toset a sensor on a measuring device and a lancet on a lancet device,respectively, as conventional, and preparation for measurement can becompleted by only a single operation of setting a lancet-integratedsensor on a measuring device. Further, the trouble of replacing a usedsensor with a new one is reduced by half.

[0297] Furthermore, since a lancet is locked with its needle tip beinghoused in a sensor, an accident due to careless exposure of the needletip is avoided.

[0298] Moreover, since a cartridge for housing plural sensors cansupport the sensors at regular intervals, it is possible to avoid suchan accident that, when a sensor is attached to a measuring device, themeasuring device damages other sensors.

1. A lancet-integrated sensor which is constituted by integrating alancet for lancing the skin of a subject to extract its bodily fluid,and a sensor body for analyzing the extracted bodily fluid, wherein thesensor body has a shape of a long and narrow strip, and the lancet isdriven along the longitudinal direction of the sensor body by anexternal driving means, thereby lancing the skin.
 2. A lancet-integratedsensor as defined in claim 1, wherein the sensor body has an internalspace through which the lancet can pass, and holds the lancet in thespace.
 3. A lancet-integrated sensor as defined in claim 2, wherein along and narrow space for housing the lancet is formed in the sensorbody.
 4. A lancet-integrated sensor as defined in any of claims 1 to 3,wherein the sensor body is obtained by bonding two thin plates together,and at least one of the two plates has a concave portion; and the lancetis stored in a space which is formed by the concave portion of the twoplates bonded together.
 5. A lancet-integrated sensor as defined in anyof claims 1 to 4, wherein when the lancet lances the skin to extract thebodily fluid, the lancet projects its needle tip from the inside of thesensor body in which the lancet is stored.
 6. A lancet-integrated sensoras defined in any of claims 1 to 5, wherein a cavity for collecting thebodily fluid is provided separately from the space in the sensor bodywhere the lancet is housed.
 7. A lancet-integrated sensor as defined inany of claims 1 to 6, wherein the space in the sensor body for housingthe lancet also serves as a cavity for collecting the bodily fluid; andthe bodily fluid is collected into the space for housing the lancet. 8.A lancet-integrated sensor as defined in any of claims 1 to 6, whereinan inlet of a cavity for collecting the bodily fluid is provided at anend of the sensor from which the needle tip of the lancet is projected.9. A lancet-integrated sensor as defined in any of claims 1 to 8,wherein the sensor body has, in-a cavity, an electrode for outputtingthe analysis result of the characteristics of the bodily fluid.
 10. Alancet-integrated sensor as defined in claim 9, wherein a connectionterminal to be connected with an external measuring device toelectrically measure the characteristics of the bodily fluid is providedat an end of the sensor body having the cavity.
 11. A lancet-integratedsensor as defined in any of claims 1 to 10, wherein a reagent thatreacts with the collected bodily fluid is provided in the cavity.
 12. Alancet-integrated sensor as defined in any of claims 1 to 10, wherein anend of the lancet on the side opposite to the needle tip projects fromthe sensor body; and the projecting end is engaged with a driving meansof the external measuring device, whereby the lancet is driven toperform the skin lancing operation.
 13. A lancet-integrated sensor asdefined in claim 12, wherein a connector to be engaged with the drivingmeans of the external measuring device is provided at the end of thelancet on the opposite side to the needle tip; and the connector isengaged with the driving means, whereby the lancet performs the skinlancing operation.
 14. A lancet-integrated sensor as defined in claim13, wherein the connector is made of a resin, and has a diameter largerthan that of the lancet.
 15. A lancet-integrated sensor as defined inany of claims 1 to 14, wherein a detachable protection cover is-fittedto the needle tip of the lancet; and the protection cover is removedduring the skin lancing operation of the lancet.
 16. A lancet-integratedsensor as defined in claim 15, wherein the protection cover has a tubepart for housing the needle tip in it, and a wide grip part forfacilitating removal of the protection cover from the lancet, which grippart is provided on the needle tip side of the tube part.
 17. Alancet-integrated sensor as defined in claim 15, wherein engagement ofthe lancet and the driving means, and attachment of the sensor bodyintegrated with the lancet to the measuring device are performed withholding the grip part of the protection cover.
 18. A lancet-integratedsensor as defined in claim 16, wherein a space in which the front end ofthe sensor body can be housed is formed in the tube part.
 19. Alancet-integrated sensor as defined in any of claims 1 to 18 beingprovided with a holder which covers the periphery of the integratedsensor body and lancet to hold them.
 20. A lancet-integrated sensor asdefined in claim 19, wherein the holder is made of a transparentmaterial.
 21. A lancet-integrated sensor as defined in any of claims 1to 20 being of a disposal type, which will be discarded after performingcollection and analysis of the bodily blood one time.
 22. A measuringdevice to which a lancet-integrated sensor that is constituted byintegrating a lancet for lancing the skin of a subject to extract itsbodily fluid, and a sensor body for analyzing the extracted bodilyfluid, is detachably attached, for measuring the characteristics of thebodily fluid collected by the lancet-integrated sensor, said measuringdevice including: a lancet driving means for driving, after thelancet-integrated sensor is attached to the measuring device, the lancetso as to lance the skin.
 23. A measuring device as defined in claim 22,wherein at least one end of the lancet-integrated sensor is projectedfrom the measuring device when attachment of the lancet-integratedsensor to the measuring device is completed.
 24. A measuring device asdefined in claim 22 or 23, wherein the lancet driving means drives thelancet of the lancet-integrated sensor so that the needle tip of thelancet is projected from the sensor only when it lances the skin tocollect the bodily fluid and, at all other times, the needle tip ishoused in the sensor.
 25. A measuring device as defined in claim 24being provided with a connector for maintaining electrical connectionwith an electrode terminal that is placed at an end of the sensor bodyof the lancet-integrated sensor, to measure the characteristics of thecollected bodily fluid by an internal electric circuit.
 26. A measuringdevice as defined in any of claims 22 to 25, wherein the lancet drivingmeans drives the lancet when it is engaged with an end of the lancet onthe opposite side to the needle tip, or when a grip part of a protectioncover is griped.
 27. A measuring device as defined in claim 26, whereinthe lancet driving means has a spring for applying a force to the lancetin the longitudinal direction of the sensor, and the force of the springis released by a press button that is provided on the measuring deviceto project the lancet.
 28. A measuring device as defined in any ofclaims 21 to 27, wherein a lancet-integrated sensor as defined in any ofclaims 15 to 18 is detachably attached to the measuring device; andattachment of the lancet-integrated sensor to the measuring device iscarried out with the tip of the lancet being covered with a protectioncover, the sensor is held by the connector of the measuring device, andan end of the lancet on the opposite side to the needle tip is supportedby the lancet driving means.
 29. A measuring device as defined in any ofclaims 22 to 28, wherein a lancet-integrated sensor as defined in any ofclaims 19 to 20 is detachably attached to the measuring device; and thesensor is held by the connector, and an end of the lancet on theopposite side to the needle tip or the grip part of the protection coveris held by the driving means, in accordance with the operation ofengaging the holder with the measuring device, so that the sensor andthe lancet are attached to the measuring device in the state where thesensor and the lancet are being held by the holder.
 30. A measuringdevice as defined in any of claims 22 to 29, wherein a lancet-integratedsensor which has been used is ejected from the measuring device bodywithout being touched with hands, by operating an operation button thatis provided on the measuring device body.
 31. A measuring device asdefined in any of claims 22 to 30, wherein the amount of projection ofthe needle tip of the lancet from the front end of the sensor isdisplayed on a display means that is provided on the measuring devicebody.
 32. A lancet-integrated sensor which is constituted by integratinga lancet having a needle for lancing skin to collect bodily fluid, and asensor for analyzing the collected bodily fluid, wherein a cavity forslidably housing a part of the lancet is formed in the sensor; and aforce is applied to the lancet in a direction opposite to the directionalong which the needle lances the skin, to house the needle in thesensor, whereby the lance and the sensor are locked with each other. 33.A lancet-integrated sensor as defined in claim 32, wherein the lancetcomprises an approximately-rectangle-shaped plate member; the needle ofthe lancet is arranged in the vicinity of the center of one of theshorter sides of the plate member so that it projects along thelongitudinal direction of the plate member; the cavity is formed in ashape approximately identical to an outline shape that is obtained whenthe lancet is slid by a predetermined amount along the longitudinaldirection thereof; and openings for projecting the needle and the otherside of the lancet to the outside of the sensor are formed at the frontend and the rear end of the sensor, respectively.
 34. Alancet-integrated sensor as defined in claim 32 or 33, wherein either aconvex portion for locking or a concave portion for locking is formed onthe lancet, and either a concave portion for locking or a convex portionfor locking which is engaged with the convex portion or the concaveportion of the lancet is formed on the sensor; and the lancet and thesensor are locked with each other when the convex portion for lockingand the concave portion for locking are engaged with each other.
 35. Alancet-integrated sensor as defined in claim 34, wherein the lancet hastwo plate-shaped projections which project from the two longer sides ofthe lancet in the width direction; the projections have the concaveportions for locking on their upper surfaces; a cavity for slidablyhousing the lancet, which is formed in the sensor, has two depressionsfor housing the two projections of the lancet, which depressions projectin the width direction of the cavity; and the depressions have theconcave portions for locking at their ceilings.
 36. A measuring devicefor performing measurement using a lancet-integrated sensor as definedin claim 33, comprising: a guide member for guiding thelancet-integrated sensor that is inserted from an opening provided on aside surface of the measuring device, thereby restricting the directionalong which the lancet-integrated sensor travels in the measuringdevice; a lancet pressing member which is pushed by a spring member inthe measuring device in a direction opposite to the direction alongwhich the lancet-integrated sensor is inserted, and is engaged with theother shorter side of the lancet that is guided toward the inside of themeasuring device by the guide member, thereby pressing the lancet towardthe opening; a locking member for fixing the lancet pressing member at apredetermined position in the measuring device when thelancet-integrated sensor is inserted deeper into the measuring device;an unlocking member for releasing fixation of the lancet pressing memberby the locking member, with manual operation; and an ejection member forapplying a force to the sensor of the lancet-integrated sensor to pushthe sensor toward the opening side, with manual operation, whichejection member is provided between the lancet pressing member-and theguide member.
 37. A measuring device for a lancet-integrated sensor asdefined in claim 36, wherein the ejection member slides an operationlever that is exposed at the main surface of the measuring device,toward the opening side, whereby a pressing member that is united withthe operation lever presses the vicinity of both sides of an end of thelancet-integrated sensor, which end is opposite to the side where thelancet lances the skin, thereby ejecting the lancet-integrated sensor.38. A measuring device for performing measurement using alancet-integrated sensor which is constituted by integrating a lancetfor lancing skin to collect bodily fluid, and a sensor for analyzing thecollected bodily fluid, wherein the measuring device for thelancet-integrated sensor has an opening on a side surface; the measuringdevice has a cavity in which the lancet-integrated sensor can be housed,which cavity is formed corresponding to the opening; a holder attachmentpart is formed on the side of the measuring device having the opening,which holder attachment part detachably attaches a holder body in whichthe lancet-integrated sensor can path through, to the measuring device;and the holder body guides the lancet-integrated sensor-when thelancet-integrated sensor is housed in the cavity and, after it is housedin the cavity, the holder body holds a portion of the lancet-integratedsensor in the vicinity of the end where the lancet lances the skin. 39.A measuring device for a lancet-integrated sensor as defined in claim38, wherein engagement portions of the holder and the holder attachmentpart have asymmetrical shapes in the vertical direction or in thehorizontal direction; and attachment of the holder to the holderattachment part is possible only when the vertical direction of theholder with respective to the holder attachment part is a predetermineddirection.
 40. A measuring device for a lancet-integrated sensor asdefined in claim 38, wherein the opening of the holder attachment partinto which the holder body is inserted has a shape of an approximatelyrectangle that is side-to-side long, with portions corresponding to thecorners of the rectangle being rounded, and the opening has smalleropenings overhanging in the width direction in the vicinities of thecenters of two sides in the longitudinal direction.
 41. A measuringdevice for a lancet-integrated-sensor as defined in claim 40, whereinthe holder body has hinge-shaped stoppers; inner sides of thehinge-shaped stoppers are fixed to the holder body; and outer sides ofthe hinge-shaped stoppers are engaged with the engagement portions ofthe holder attachment part.
 42. A measuring device for alancet-integrated sensor as defined in claim 40, wherein the holder bodyhas a peripheral edge part that extends along the surface of theopening, at the periphery of the opening excluding the smaller openings,on the side where the holder body is attached to the measuring device;the hinge-shaped stoppers are provided in portions of the peripheraledge part corresponding to the smaller openings; and the hinge-shapedstoppers are obtained by extending band-shaped elastic members in thedirection along which the lancet-integrated sensor is impacted into theholder body, and bending the elastic members outward at 180°.
 43. Ameasuring device for a lancet-integrated sensor as defined in claim 42,wherein each of the hinge-shaped stoppers has a clip member at the frontend of the band-shaped elastic member, which clip member is thicker thanthe elastic member, and performs positioning when the holder body islatched in the opening.
 44. A biosensor cartridge for housing pluralbiosensors, each having a reagent layer for detecting a specificcomponent in bodily fluid of a subject, and an electrode for taking outan electric signal indicating that the reagent layer detects thespecific component, wherein a cartridge body has, at an end of its uppersurface, a hinge for rotatably fixing a lid that covers the cartridge;the cartridge body has plural slits for perpendicularly supporting therespective biosensors; and the plural slits are formed in parallel witheach other, from the upper surface toward the lower surface of thecartridge body, at regular intervals which allow an insertion slot of ameasuring device for performing measurement using a target biosensor tobe inserted without touching biosensors adjacent to the targetbiosensor.
 45. A biosensor cartridge as defined in claim 44, wherein thecartridge body to which the lid is attached is a rectangularparallelepiped in shape.
 46. A biosensor cartridge as defined in claim45, wherein the lid is a hollow rectangular parallelepiped in shape, andhas an opening at a portion opposed to the upper surface of thecartridge body.
 47. A biosensor cartridge as defined in claim 44,wherein the bottom of each slit has a shape that conforms to the shapeof the front end of the biosensor.
 48. A biosensor cartridge as definedin claim 47, wherein the front end of the biosensor is semi-circular inshape.
 49. A biosensor cartridge as defined in claim 44, wherein thehinge is constituted by a pair of bearings each having a side-to-sidelong bearing hole that projects outward along the longitudinal directionof the cartridge body from an end of the upper surface of the cartridgebody, and a pair of axial projections which are provided at an end ofthe lid, and serve as fulcra when being smooth-movably engaged with thebearings to rotate the lid; a peripheral edge part is formed at theperiphery of the upper surface of the cartridge body, which part extendsin a direction perpendicular to the side walls of the cartridge body,and has plural notches; reverse-L-shaped projections are formed on thesame plane as the side walls of the lid, in positions correspondingto-the notches of the peripheral edge part, at the periphery of theopening of the lid; and a sealing member having elasticity is formed onthe upper surface of the peripheral edge part.
 50. A biosensor cartridgefor housing plural lancet-integrated biosensors, each being constitutedby integrating a biosensor having a reagent layer for detecting aspecific component in bodily fluid of a subject, and an electrode fortaking out an electric signal indicating that the reagent layer detectsthe specific component, with a lancet for collecting the bodily fluid ofthe subject, wherein the cartridge body has, at an end of its uppersurface, a hinge for rotatably fixing a lid that covers the cartridgebody; the cartridge body has plural grooves for perpendicularlysupporting the lancet-integrated biosensors; and the plural grooves areformed in parallel with each other, from the upper surface toward thelower surface of the cartridge body, at regular intervals which allow aninsertion slot of a measuring device for performing measurement using atarget biosensor to be inserted without touching biosensors adjacent tothe target biosensor.
 51. A biosensor cartridge as defined in claim 50,wherein the lancet-integrated biosensor includes anapproximately-square-shaped and narrow protector for protecting thelancet that projects from the lancet-integrated biosensor in its unusedstate, a sensor body in which the lancet is smooth-movably housed, thesensor body being approximately rectangle in shape, has a front endbeing semi-circular in shape, and is a little wider than the protector,and a connector which is provided on the lancet, protrudes backward fromthe sensor body, and has a width approximately equal to the width of thesensor body; wherein each of the plural grooves comprises a narrow firstgroove which is provided at the lowest surface side of the cartridgebody, and conforms to the shape of the protector, a second groove whichis wider than the first groove, is provided above the first groove, andconforms to the shape of a portion of the sensor body, and a thirdgroove which is wider than the second groove, is provided above thesecond groove, and conforms to the shape of the insertion slot part ofthe measuring device into which the sensor body is inserted.
 52. Abiosensor cartridge as defined in claim 51, wherein the insertion slotstores the sensor body into a cavity which penetrates a pillar-shapedprojection that projects from a side surface of the measuring device;and the connector is stored in the cavity that extends into themeasuring device.
 53. A measuring device for performing measurementusing a lancet-integrated sensor that is attached thereto, saidlancet-integrated sensor being constituted by integrating a lancet forlancing skin to collect bodily fluid, and a sensor for analyzing theextracted bodily fluid, said measuring device including: a drive meansfor driving the lancet in a direction in which the lancet lances theskin, along the longitudinal direction of the sensor, from the standbyposition of the lancet; wherein, after the drive means has driven thelancet in the direction in which the lancet lances the skin, the drivemeans can drive the lancet back to the standby position whilemaintaining the state where the lancet-integrated sensor is attached tothe measuring device.
 54. A measuring device for a lancet-integratedsensor as defined in claim 53, wherein the drive means has a shaft towhich a connector receiver is fixed at an end on the side where thelancet lances the skin, which connector receiver receives an end of thelancet on the side opposite to the side where the lancet lances theskin; a pull stick for driving the lancet back in a direction oppositeto the direction in which the lancet lances the skin is disposed on anend of the shaft on the side opposite to the side where the lancetlances the skin; and the connector receiver is provided with a clawportion which is unlocked by pressing an operation button to start theoperation of the drive means, and stops the motion of the connectorreceiver against a force applied by a spring that is provided on theshaft to move the connector receiver in the direction in which thelancet lances the skin.
 55. A measuring device for a lancet-integratedsensor as defined in claim 54, wherein the measuring device has, in itsinternal cavity, a support member for slidably supporting the shaft inthe vicinity of its center; and the spring is a coil spring which isplaced between the support member of the shaft and the connectorreceiver.
 56. A measuring device for a lancet-integrated sensor asdefined in claim 54, wherein the pull stick has an opening which isformed at an end of the side where the lancet lances the skin; an end ofthe shaft on the side opposite to the side where the lancet lances theskin is slidably housed in the pull stick through the opening; and theend of the shaft on the side opposite to the side where the lancetlances the skin has a slip-out prevention member for preventing the endof the shaft to slipping out of the pull stick toward the side where thelancet lances the skin.
 57. A measuring device for a lancet-integratedsensor as defined in claim 54, wherein the driving means is providedwith a lancet projection amount adjuster for adjusting the amount ofprojection of the needle of the lancet that lances the skin, whichdriving means is placed between the measuring device and the pull stick.58. A measuring device for a lancet-integrated sensor as defined inclaim 57, wherein the pull stick is approximately cylindrical in shape,and an end of the pull stick on the side opposite to the side where thelancet lances the skin has a handle part having a portion of a diameterlarger than the diameter of the cylindrical part; the lancet projectionamount adjuster is approximately cylindrical in shape, and an end of theadjuster on the side opposite to the side where the lancet lances theskin has an opening having a diameter equal to the diameter of thecylindrical part of the pull stick; and the cylindrical part is slidablyhoused through the opening, and the cylindrical part is screwed into ascrew hole that is formed on a side surface of the measuring device onthe side opposite to the side where the lancet lances the skin, towardthe inside of the measuring device, whereby the cylindrical part rotatesin the screw direction or in the opposite direction to adjust the amountof projection of the lancet.